Alerta De Seguridad O Notificaciones De Seguridad para Sigma® implantable pacemakers

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.

Failure of interconnecting wires within the pacemaker may cause:loss of pacing output from atrial and/or ventricular ports
premature battery depletion
intermittent or total loss of telemetry
undersensing
high lead impedance values
loss of rate response
device reset to manufacturer’s default settingsMedtronic has advised MHRA that some Sigma® pacemakers from the above model ranges may be subject to failures which could result in any of the behaviours listed on page 1. Medtronic issued letters to clinicians about this issue in November 2005 (See Appendices 1 and 2).Medtronic’s analyses of 19 returned Sigma® pacemakers has identified a failure mode where separation of interconnecting wires between certain electronic components, can seriously affect the performance of the device.Analysis has identified that the wire separation is associated with the use of an incorrect cleaning solvent during circuit board manufacturing that contained an antioxidant. The solvent, which was only used for a limited manufacturing period, resulted in surface contamination of electrical connection areas prior to wire bond connection. Extensive testing and analysis by Medtronic has now confirmed that use of this cleaning solvent can lead to a reduction in strength of the wire bond connections and these connections may separate over time. No mean time to failure has been established for this failure mode however there have been no failures less than 17 months post implant.There is no provocative testing that can be performed to identify when any of the affected devices may fail.Failure rates are currently low at approximately 0.05%. To date 19 Sigma® failures have been confirmed where wire bond connections have separated. Medtronic estimate that approximately 28,000 devices remain implanted worldwide. In the UK 1 failure by this mode has been confirmed to date out of an estimated 1700 devices that remain implanted. The UK failure occurred at implant duration of 36 months with the patient presenting with shortness of breath. Subsequent clinical checking confirmed no pacing output or telemetry.Medtronic have received no reports of serious injuries or deaths due to this problem.Affected Sigma® pacemakers may be identified through accessing the Medtronic website http://SigmaSNList.medtronic.com