BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3922823 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12727
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT TO THEIR DENTIST ON (B)(6) 2014 AND THEY TRIED TO TURN THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BACK ON (B)(6) 2014 BUT THEY COULD NOT. IT WAS STATED THE PATIENT TRIED TO COMMUNICATE WITH THEIR INS BOTH WITH AND WITHOUT THE ANTENNA AND THEY COULD NOT MAKE AN ADJUSTMENT EITHER WITH OR WITHOUT THE ANTENNA ATTACHED. IT WAS STATED THE PROGRAMMER WOULD NOT DO TELEMETRY WITH OR WITHOUT THE ANTENNA. ANALYSIS OF THE PROGRAMMER SHOWED THE TELEMETRY PROBLEM WITH THE PROGRAMMER WAS UNVERIFIED. IT WAS STATED THE ANTENNA JACK WAS TARNISHED AND THE BOTTOM CASE ASSEMBLY WAS CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399975 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR