BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III

    MDR report key: 4833200 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11249
    Event Type
    Death
    Date Received
    June 10, 2015
    Date of Event
    March 30, 2015
    Report Date
    May 14, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 419478 LEAD IMPLANTED: (B)(6) 2007; 5068-45 LEAD, IMPLANTED: (B)(6) 1999. (B)(4). EVALUATION SUMMARY: PRELIMINARY ANALYSIS FOUND THAT THE DEVICE HAD MET ITS EXPECTED LONGEVITY BASED ON RECEIVED PARAMETERS. ANALYSIS OF THE BATTERY CELL FOUND THAT IT DEVELOPED HIGH INTERNAL RESISTANCE, WITH ELECTRICAL CHARACTERISTICS CONSISTENT WITH A RESISTIVE FILM GROWTH BETWEEN THE CATHODE AND CATHODE CURRENT COLLECTOR.

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. IF FOLLOW-UP WAS REQUIRED, EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A REPORT WAS ALSO RECEIVED VIA VOLUNTARY MEDWATCH MW5056923. (B)(4).

    Additional Manufacturer Narrative · 1

    AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S PHYSICIAN INDICATING THAT THE PATIENT'S CAUSE OF DEATH WAS CARDIOPULMONARY AND RENAL FAILURE. THE PHYSICIAN ALSO STATED THAT THE PATIENT'S DEATH WAS RELATED TO THE DEVICE SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENTS DAUGHTER WHICH REPORTED THAT THE PATIENT SUFFERED A STROKE TO THEIR SPINAL CORD AND LOST USE OF THEIR LEGS. THE PATIENT'S DAUGHTER ALSO ALLEGES THAT WHILE THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) DID NOT DIRECTLY RESULTS IN THE PATIENT'S DEATH, IT DID CONTRIBUTE TO SERIOUS COMPLICATIONS THAT LEAD TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT THE PATIENT IS DECEASED. IT WAS ALLEGED BY THE PATIENT'S PHYSICIAN THAT THE BRADYCARDIA CONTRIBUTED TO THE DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT IN COMPLETE HEART BLOCK HEART WITH A HEART RATE OF 30 BPM. THE PATIENT ALSO HAD SHORTNESS OF BREATH AND WEAKNESS. THE PATIENT WAS SCHEDULED FOR A DEVICE CHANGEOUT DUE THE UNEXPECTED LONGEVITY. DURING THE DEVICE CHANGE OUT, THE DEVICE HAD NO OUTPUT AND COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374940 INSYNC III PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO 8042B

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Death| H| R