BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5514080 · Received March 21, 2016

    Report

    Report Number
    3004209178-2016-04994
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    March 22, 2010
    Report Date
    March 21, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-28, LOT# V173541, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT RECORDING WELL AND THE PATIENT HAD NO BENEFIT FROM IT. THEY TRIED VARIOUS OPTIONS ON THE PATIENT TO REPROGRAM IT BUT THE PATIENT DID NOT SEEM TO BENEFIT FROM IT. THE IPG WAS REMOVED AND THE LEAD WAS REPLACED. THE PATIENT WAS INDICATED FOR GASTROINTESTINAL/ PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169309 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention