BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3526347 · Received December 18, 2013

    Report

    Report Number
    3004209178-2013-23734
    Event Type
    Injury
    Date Received
    December 18, 2013
    Report Date
    December 3, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V842736, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT NEEDED TO HAVE THEIR DEVICE CHECKED BECAUSE FOR THE LAST 2-3 MONTHS THEY HAD BEEN HAVING TO GO TO THE BATHROOM ALL THE TIME. IT WAS LATER REPORTED THE CAUSE OF THE EVENT WAS THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DIED. IT WAS STATED THE BATTERY DEPLETION WAS PREMATURE AND A REPLACEMENT WAS PLANNED BUT HAD NOT YET OCCURRED. IT WAS NOTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661334 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention