BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA SR

    MDR report key: 3855259 · Received June 9, 2014

    Report

    Report Number
    9614453-2014-01066
    Event Type
    Death
    Date Received
    June 9, 2014
    Date of Event
    February 15, 2013
    Report Date
    May 12, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE PATIENT'S SPOUSE THAT APPROXIMATELY ONE MONTH FOLLOWING THE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT KNEELED OVER IN EXTREME PAIN AND WAS HOSPITALIZED FOR 10 DAYS. THE PATIENT WAS IN A SEMI-CONSCIOUS STATE AND WAS TREATED WITH A LAXATIVE. THE PATIENT WAS NOT PUT BACK ON HIS ROUTINE MEDICATIONS FOR TREATMENT OF DIABETES, HIGH CHOLESTEROL, HIGH BLOOD PRESSURE, GASTRO ESOPHAGEAL REGURGITATION DISEASE, AND AN ANTICOAGULANT. THE PATIENT WAS TRANSPORTED BACK HOME VIA AIR AMBULANCE. DURING THE FLIGHT, THE PATIENT'S HEART STOPPED AND CPR WAS PERFORMED BUT WAS UNSUCCESSFUL. AN AUTOPSY WAS REQUESTED BY THE PATIENT'S SPOUSE AND SHE WAS TOLD IT WAS NOT POSSIBLE. THE PATIENT'S SPOUSE INQUIRED WHY HE COULD NOT BE REVIVED AND ASKED IF THE IPG MALFUNCTIONED. IT WAS ALSO REPORTED THAT 2 MONTHS PRIOR TO DEATH, THE PATIENT WAS NOTED TO HAVE BLOOD IN THE URINE WHICH WAS LEFT UNTREATED AND THE PATIENT SUFFERED A MYOCARDIAL INFARCTION 2 YEARS PRIOR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334914 ADAPTA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADSR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death