BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3252405 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12424
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 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
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V588865, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DIZZINESS WAS ADDRESSED ¿FOR REASONS NOT RELATED TO THE DEVICE.¿ IT WAS NOTED THAT THE PATIENT SAID THAT NO ONE WAS FOLLOWING THE DEVICE AND THE DEVICE WAS NOT TURNED ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THE PATIENT HAD STIMULATION TURNED OFF FOR OVER A YEAR. THE REPORTER STATED THE PATIENT HAD DIZZINESS AND SHOCKING IN THE GROIN AREA, BUT SINCE THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN TURNED OFF THE SHOCKING HAS RESOLVED. IT WAS NOTED THE PATIENT STILL HAD DIZZINESS AFTER THE INS WAS TURNED OFF. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352260 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1