BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3558846 · Received January 7, 2014

    Report

    Report Number
    3004209178-2014-00285
    Event Type
    Injury
    Date Received
    January 7, 2014
    Report Date
    December 18, 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
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V042307, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. THE BATTERY WAS AT NORMAL END OF LIFE. THERE WAS NO TELEMETRY AND NO OUTPUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS REMOVED AND REPLACED BECAUSE IT WAS ¿NOT WORKING.¿ THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10868 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention