BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3925615 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12779
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    June 4, 2026
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA03XEG, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UN KNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED AS SHE HAD A FALL AND DEVELOPED A SHORT WHICH SHORTED OUT THE INS AND ALSO CAUSED THE INS TO BECOME HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404174 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention