BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3181433 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10673
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 31, 2013
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V091741, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S NEUROSTIMULATOR WASN'T WORKING AND WOULDN'T RESPOND WHEN THEY WERE USING THE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE BATTERY WAS DEPLETED AND IT WAS NOTED THE PATIENT WAS NOT SATISFIED WITH BATTERY LONGEVITY. IT WAS NOTED THE STIMULATOR WAS CHANGED FOUR YEARS AFTER THE IMPLANT IN 2008 AND THE HEALTH CARE PROFESSIONAL STATED IT ¿DEPLETED VERY QUICKLY.¿ IT WAS NOTED THE PATIENT HAD STIMULATION AT 3.9 AND WAS WONDERING IF THAT WOULD DEPLETE THE BATTERY QUICKLY. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS BATTERY RAN OUT. PREMATURE BATTERY DEPLETION WAS NOTED. REPLACEMENT OF THE INS OCCURRED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282172 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention