Alerta De Seguridad O Notificaciones De Seguridad para INSIGNIA and NEXUS implantable pacemakers

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Guidant.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2005/067
  • Fecha
    2005-12-08
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
    Device may exhibit:intermittent or permanent loss of pacing output without warning
    intermittent or permanent loss of telemetry
    reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.Guidant has informed MHRA that all INSIGNIA and NEXUS implantable pacemakers may be subject to either one or two separate failure modes each having a different root cause.Affected devices will exhibit one or more of the following:intermittent or permanent loss of pacing output without warning
    intermittent or permanent loss of telemetry
    reversion to ventricular inhibited pacing (VVI), and/or a reset warning message upon interrogation.Although there have been no reports of death as a result of these failure modes, serious health complications may result from the abnormal device behaviours associated with these failure modes.Details of the two failure modes are described below:
    Device Family
    Model Numbers
    NEXUS Entra SSI
    1325, 1326
    NEXUS Entra DDD
    1425, 1426
    NEXUS Entra SR
    1395, 1398
    NEXUS Entra DR
    1466, 1494, 1495
    NEXUS Ultra SR
    1390
    NEXUS Ultra DR
    1490, 1491
    NEXUS Plus SR
    1394
    NEXUS Plus DR
    1467, 1468
    NEXUS AVT SSI
    1328
    NEXUS AVT VDD
    1428
    NEXUS AVT DDD
    1432
    NEXUS AVT SR
    1392
    NEXUS AVT DR
    1492NB. Not all models are available in the UKA list of UK serial numbers for devices distributed on or before 12 March 2004, affected by the first failure mode can be found in Appendix 1.
    Device Family
    Model Numbers
    INSIGNIA Entra SSI
    0484, 0485
    INSIGNIA Entra DDD
    0985, 0986
    INSIGNIA Entra SR
    1195, 1198
    INSIGNIA Entra DR
    1294, 1295, 1296
    INSIGNIA Ultra SR
    1190
    INSIGNIA Ultra DR
    1290, 1291
    INSIGNIA Plus SR
    1194
    INSIGNIA Plus DR
    1297, 1298
    INSIGNIA AVT SSI
    482
    INSIGNIA AVT VDD
    882
    INSIGNIA AVT DDD
    982
    INSIGNIA AVT SR
    1192
    INSIGNIA AVT DR
    1292
    Guidant has identified the potential for loss of pacing output and/or telemetry in a subset of INSIGNIA and NEXUS devices distributed prior to 12 March 2004.Guidant has confirmed that the root cause of this malfunction is the obstruction of a crystal timing component by loose material used in the component’s manufacturer. When this timing component is disrupted all device operations such as pacing, telemetry and magnet response may be prevented and the device can cease to function.To date, all device malfunctions associated with this failure mode have occurred within the first 22 months of implantation. Guidant believes that the likelihood of this malfunction occurring decreases with implant time, with a mean time to failure of seven months.Device failure is rare. As of November 2005, Guidant has received three reports of syncope and six reports of bradycardia requiring emergency hospitalisation. Engineering analysis by Guidant of an explanted device revealed that it had failed briefly but then resumed functioning with no detectable indication to the physician during routine follow-up.Guidant has received 37 confirmed reports of device malfunction associated with this failure mode: 7 devices exhibited a no output condition during the implant procedure; 21 devices exhibited a no output condition post implant procedure and 9 devices reverted to VVI pacing at 65 bpm.Out of 49,500 devices distributed prior to 12 March 2004, Guidant estimates that approximately 41,000 devices remain implanted, with approximately 2,200 implanted in the UK.Guidant predicts that up to 14 additional devices may malfunction worldwide over the remaining lifetime of the implanted products. Guidant has ensured corrective measures to address this issue have been implemented.MHRA has received two UK reports of syncope associated with these devices. Guidant issued information related to this problem to UK clinicians on 29 September 2005 (see Appendix 2).
    Guidant has identified that all INSIGNIA and NEXUS devices may exhibit a no output condition during verification testing prior to implant or during implantation. No malfunctions have been observed after successful verification of the device at implant.As of November 2005, Guidant has received 17 confirmed reports of device malfunction at pre-implant testing or during implantation out of approximately 341,000 devices distributed worldwide. In one (non-UK) report a pacemaker dependent patient experienced syncope and was resuscitated following cardiac arrest. This was associated with loss of pacing output during an elective pacemaker replacement procedure.There have been no reports of device malfunction at pre-implant testing or during implantation in the UK to date. The number of potentially affected devices in the UK is approximately 11,000.Guidant has yet to determine a specific root cause for this failure mode and continues to investigate this failure.Guidant will issue further advice when more information is available.Guidant also issued information related to this problem on 29 September 2005 (see Appendix 2).MHRA will continue to monitor both these situations.
  • Causa
    (guidant) device may have intermittent or permanent loss of pacing output without warning, intermittent permanent loss of telemetry, reversion to ventricular inhibited pacing (vvi), and/or reset warning message upon interrogation. (mda/2005/067).

Device

  • Modelo / Serial
  • Descripción del producto
    Guidant INSIGNIA and NEXUS implantable pacemakers - specific serial numbers distributed in the UKDue to the number of products involved it is not possible to include the list of serial numbers on this page. A comprehensive list of serial numbers of affected devices distributed in the UK can be found in the following attachments:MDA/2005/070 - with model numbersList of serial numbers
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Enquiries to the manufacturer should be addressed to:Ms Jayne Puckeridge Regulatory Affairs Manager Guidant Limited Hampshire International Business Park Crockford Lane Chineham Basingstoke RG24 8WHTel: 01256 374 010Fax: 01256 374 014E-mail: jpuckeri@guidant.com
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHRA