BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2549325 · Received April 26, 2012

    Report

    Report Number
    3004209178-2012-02694
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Report Date
    March 31, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3093-28, LOT#: V082173, IMPLANTED: 2008 (B)(6), EXPLANTED: NA. PROGRAMMER: MODEL 3037, SERIAL#: (B)(4). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NON-COMPLIANT WITH FOLLOWING UP WITH HER HEALTH CARE PROVIDER (HCP) AND NO CAUSE OF EVENT WAS KNOWN BY HER PHYSICIAN. SHE HAD NOT BEEN IN SINCE (B)(6) 2011, AND DID NOT REPORT ANY PROBLEMS AT THE TIME. THE PATIENT DECLINED TO MAKE AN APPOINTMENT WHEN CONTACTED BY HER HCP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT NO STIMULATION SENSATION FOR THE PAST MONTH. THE PATIENT NOTED THAT A LOSS OF STIMULATION HAD HAPPENED BEFORE. A REVISION WAS PERFORMED APPROXIMATELY ONE YEAR AGO WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVED FROM THE LEFT TO THE RIGHT SIDE OF HER BODY. SIX MONTHS LATER, THE INS WAS "NOT FUNCTIONING PROPERLY" AND WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1