BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3516984 · Received December 12, 2013

    Report

    Report Number
    3004209178-2013-23459
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Report Date
    November 27, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V183293, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD BEEN HAVING LEAKAGE SINCE HER CAR ACCIDENT TWO WEEKS PRIOR TO THE REPORT. THE PATIENT STATED THAT HER CAR WAS ¿T-BONED.¿ THE PATIENT HAD BEEN TRYING TO ADJUST STIMULATION, BUT IT WAS NOT WORKING AS IT WAS SUPPOSED TO. THE PATIENT STATED THAT THE IMPLANT TURNED ITSELF OFF AND SHE CONFIRMED IT WITH HER PATIENT PROGRAMMER. 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
    650894 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1