BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III

    MDR report key: 1953066 · Received January 7, 2011

    Report

    Report Number
    6000094-2011-00006
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    August 27, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO WEEKS AFTER DISCHARGE. THE PATIENT WAS PACEMAKER DEPENDENT. IT WAS ALSO NOTED BY THE PHYSICIAN THAT THE PATIENT BE OBSERVED AND STRONGER BEFORE THE LEAD REPLACEMENT PROCEDURE AND THAT THE LEAD WAS IN A STABLE POSITION. THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED LESS THAN TWO MONTHS AFTER THE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR AND LEFT VENTRICULAR LEAD. IT WAS ALSO REPORTED THAT WHEN THE PATIENT CAME IN FOR FOLLOW-UP, APPROXIMATELY ONE MONTH PRIOR TO THE TIME OF DEATH, INTERROGATION OF THE DEVICE AND A CHEST X-RAY REVEALED THAT THE LEFT VENTRICULAR LEAD WAS DISLODGED. THE PATIENT WAS ADMITTED TO THE HOSPITAL THE NEXT DAY FOR CHRONIC DIARRHEA AND DEHYDRATION THAT HAD BEEN OCCURRING FOR OVER A MONTH. DURING THE HOSPITAL STAY THE PATIENT RECEIVED TREATMENT FOR GASTROINTESTINAL MANAGEMENT. ALL STOOL CULTURES WERE NEGATIVE. DURING THE HOSPITAL STAY THE PATIENT WAS FOUND TO HAVE AN ACUTE ONSET OF CHRONIC SYSTOLIC CONGESTIVE HEART FAILURE AND DIURETICS WERE RESTARTED AND ADJUSTED. IT WAS DETERMINED THAT THE PATIENT WAS TOO WEAK FOR LEAD REVISION AND WOULD BE DISCHARGED TO A SKILLED NURSING FACILITY TO REGAIN STRENGTH. THE HOSPITAL STAY LASTED ELEVEN DAYS AND THE PATIENT DIED APPROXIMATELY:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H| L| R 5076X2 IMPLANTABLE PACING LEAD