BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2772490 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08885
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 10, 2012
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V979273, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT. PATIENT LAST FELT STIMULATION ON (B)(6) 2012. PATIENT LAST TRIED TO ADJUST STIMULATION WAS ON THE MORNING OF THE DATE OF THIS REPORT BUT SHE COULD NOT. WHEN SHE PLUGGED ANTENNA IN, SHE WAS ABLE TO ADJUST. PATIENT HAD TROUBLE HOLDING HER BLADDER SINCE (B)(6). SHE WAS ON PROGRAM 2 AT 1.5 VOLTS. AFTER THE CHANGES WERE MADE, PATIENT WAS ON PROGRAM 4 AT 0.8 VOLT. THIS SETTING FELT LIKE A TINGLE BUT WAS NOT COMFORTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. REPROGRAMMING WAS DONE ON (B)(6) 2012 AND PATIENT HAD NOT BEEN SEEN SINCE. THE LAST THE HEALTH CARE PROVIDER KNEW, THE PATIENT HAD NO REPORTED PROBLEMS AND THAT THE PATIENT WAS HAVING AN EXCELLENT OUTCOME. HEALTH CARE PROVIDER WILL CONTACT PATIENT FOR FOLLOW UP. NO FURTHER INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1