BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2891473 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12403
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 7, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V073706. 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 IMPLANT WAS REPLACED BECAUSE THE "WIRE HAD COME OUT." IT WAS LATER STATED THE IMPLANT HAD MOVED AND FLIPPED OVER BUT THE EXACT DETAILS WERE UNKNOWN. FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE CAUSE OF THE EVENT WAS BUTTOCK AND LEG PAIN. IT WAS ALSO NOTED THERE WAS AN IMPLANTABLE NEUROSTIMULATOR (INS) INVERSION. AN X-RAY WAS DONE AND LEAD WAS IN NORMAL LOCATION AND THERE WAS SEVERE OSTEOPENIA. REPROGRAMMING WAS DONE AND THERE WAS NO CHANGE IN BUTTOCK AND LEG PAIN AND THERE WERE NO IMPEDANCES NOTED. THE BATTERY HAD FLIPPED AND TWISTED IN POCKET AND A REVISION WAS DONE. THE PATIENT DID REQUIRE HOSPITALIZATION AND RECOVERED WITHOUT SEQUELA.

    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 Hospitalization| R