BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2944495 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01333
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 23, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED:(B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S STIMULATOR 'DOES NOT WORK.' THE PATIENT HAD EXPRESSED FRUSTRATION WITH THE WHOLE PROCESS AND THE STIMULATION SYSTEM. IT WAS STATED THAT THE PATIENT'S IMPLANT HAS NOT 'WORKED' FOR TWO YEARS. IT WAS REPORTED THAT THE PATIENT HAS NOT HAD STIMULATION FOR TWO YEARS AND SHE COULD NOT REMEMBER IF SHE HAD TURNED THE STIMULATION OFF OR IF IT JUST STOPPED WORKING. THE PATIENT DID NOT WANT STIMULATION ON BECAUSE IT WOULD IT PRODUCE A 'SHARP PAIN' IN HER PELVIC AREA. THE LAST TIME THE PATIENT MET WITH HER DOCTOR OR MEDTRONIC REPRESENTATIVE WAS IN 2009. THE PATIENT ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT WHEN THE PATIENT WAS INITIALLY IMPLANTED IN 2006 SHE GOT RELIEF FOR 'A COUPLE OF YEARS' THEN 'IT ALL WENT DOWN HILL AFTER THAT.' THE PATIENT DID NOT EXPRESS FAITH IN HER DOCTOR AND STATED THAT SHE HAD FOUND A DIFFERENT DOCTOR WHO WAS FAMILIAR WITH INTERSTIMULATION. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #3007566237-2013-00377 FOR INFORMATION ON A RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48224 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1