Events

Retiro De Equipo (Recall) de Device Recall Paradym DR Model 8550 and Paradym VR Model 8250

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por ela Medical Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58767
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2609-2011
  • Fecha de inicio del evento
    2011-05-02
  • Fecha de publicación del evento
    2011-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100275
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Defibrillator, implantable, dual chamber - Product Code MRM
  • Causa
    On february 28, 2011, the company discovered that since the beginning of the us commercial distribution of paradym dr 8550 and paradym vr 8250 icds in october 2010, the devices included an incorrect version of the patient booklet. the company determined that there is no risk of adverse event associated with this labeling error.
  • Acción
    Sorin CRM USA instructed its field representatives on April 27, 2011 via a conference call to attach the correct Patient Booklet (ref. N582,) as an addendum to the device's external packaging, along with a cover letter "Quality Note" dated May 2, 2011 explaining the discrepancy. The field representatives were fedexed the information on May 2, 2011. The letter instructed the Field Representative to attach the correct patient booklet and an addendum, to the outside of the device box. Field Representatives were asked to complete the acknowledgement form by identifying S/N's in which they attached the pouch and their signature of completion and fax the form to 866-500-6096 or e-mail a scanned copy to sorin.ptusa.sorin.com. For questions regarding this recall call 877-663-7674. " For affected units that were already implanted as of April 27, 2011, the patient booklet given to the patient may include information written by the physician or hospital staff that is related to the implanted system (ICD and leads), physician references and patient medications. For this reason and given the fact that the company determined that there is no risk for the patient associated with this labeling error, the company decided to not replace the patient booklet for this population.

Device

Device Recall Paradym DR Model 8550 and Paradym VR Model 8250
  • Modelo / Serial
    Serial 001YF024 004YF005 004YF019 004YF05C 004YF058 004YF081 004YF082 004YF084 005YF068 006YF075 008YF057 013YF04E 016YF02A 016YF049 016YF055 016YF058 017YF014 018YF00C 018YF01F 021YF03B 021YF031 021YF048 022YF01B 022YF02F 022YF03B 022YF031 022YF037 022YF043 022YF05A 022YF058 022YF067 023YF0B1 023YF016 023YF03F 023YF04C 023YF045 023YF089 023YF104 023YF12A 023YF129 023YF162 023YF173 024YF005 024YF034 025YF0B0 025YF0B4 025YF0C1 025YF0F2 025YF0F8 025YF06B 025YF07E 025YF08E 025YF094 025YF096 025YF117 026YF0BD 026YF0B0 026YF0E4 026YF02F 026YF028 026YF033 026YF06D 026YF068 026YF08F 028YF007 028YF01A 028YF01F 029YF001 029YF016 029YF03E 029YF05C 029YF1B5 029YF1DF 029YF11E 029YF15D 029YF204 030YF0E9 030YF004 030YF03F 030YF030 030YF061 030YF073 030YF1C2 030YF131 030YF139 030YF145 030YF152 030YF155 030YF16F 031YF039 032YF005 034YF011 034YF014 034YF016 034YF018 034YF024 037YF085 038YF065 041YF057 904YF033 932YF013 935YF010 936YF076 945YF024 003YG06D 004YG00D 004YG003 004YG012 004YG017 004YG03E 004YG031 004YG04F 004YG042 004YG043 004YG05A 004YG05D 004YG053 004YG056 004YG06F 004YG063 004YG064 004YG07E 004YG075 005YG00A 005YG048 005YG06B 005YG070 005YG074 005YG08F 006YG089 008YG03F 014YG03E 014YG092 015YG07B 016YG023 016YG026 016YG029 016YG04A 016YG04C 016YG05C 017YG00F 017YG03A 017YG050 018YG00F 018YG059 019YG032 020YG00D 020YG00F 020YG001 020YG01B 020YG017 020YG020 020YG026 020YG027 020YG03A 020YG035 021YG01E 021YG04C 021YG041 022YG026 022YG044 022YG069 023YG0B2 023YG0B3 023YG0C0 023YG01A 023YG086 023YG094 023YG101 023YG108 023YG137 023YG14D 023YG148 023YG16A 023YG16B 023YG160 023YG17A 024YG025 024YG044 024YG064 024YG07A 024YG08E 024YG08F 025YG0A3 025YG0A6 025YG05C 025YG064 025YG080 025YG095 025YG113 025YG119 026YG0A5 026YG0A9 026YG0B2 026YG0D1 026YG03C 026YG035 026YG036 026YG037 026YG038 026YG071 026YG08C 026YG090 026YG096 026YG098 026YG112 028YG037 029YG0C7 029YG0DA 029YG02A 029YG079 029YG08D 029YG1AD 029YG12A 029YG12C 029YG169 029YG178 029YG19A 030YG0AB 030YG0A0 030YG0BD 030YG0B7 030YG0EB 030YG0E2 030YG0E8 030YG0F0 030YG0F6 030YG039 030YG063 030YG1AC 030YG11F 030YG13C 030YG134 030YG14A 030YG14F 030YG141 030YG144 030YG149 030YG160 030YG17A 030YG195 031YG01C 031YG01D 031YG02D 031YG055 032YG0C9 032YG001 032YG003 032YG017 032YG029 032YG033 032YG035 032YG036 032YG054 032YG058 032YG067 032YG081 034YG00A 034YG00D 034YG03D 034YG041 034YG046 034YG051 037YG0B7 037YG0CC 037YG0D0 037YG067 041YG05D 835YG073 923YG037 925YG006 933YG0B9 944YG005 945YG005 947YG005
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, AZ, AR, CA, CO, CT, FL, GA, IA, MA, MI, MO, MS, NJ, NY, NC, OH, OK, PA, SC,A TN,T X, and WA.
  • Descripción del producto
    Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy || PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).
  • Manufacturer
    ela Medical Llc

Manufacturer

ela Medical Llc
  • Dirección del fabricante
    ela Medical Llc, 2905 Northwest Blvd Ste 40, Plymouth MN 55441-2673
  • Source
    USFDA