BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2835491 · Received November 16, 2012

    Report

    Report Number
    3004209178-2012-10374
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Report Date
    October 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT#: V042643, IMPLANTED: (B)(6) 2007, 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 SOMEONE FROM THE MANUFACTURER CALLED THE PATIENT AND TOLD HER THAT HER LEAD WAS DEFECTIVE AND CAUSING SHOCKING, AS WELL AS PROVIDING THE POTENTIAL FOR CARDIAC EVENTS, HOWEVER THERE WAS NO RECORD OF THIS CALL. IT WAS NOTED THAT THE PATIENT'S INS WAS PROBABLY CLOSE TO DEPLETION, THOUGH IT HAD BEEN CHECKED BY THE HCP ON (B)(6) AND WAS OK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO MALFUNCTIONS WERE SEEN WITH THE PATIENT'S SYSTEM, THOUGH THE INS WAS SET TO DEPLETE WITHIN TWO MONTHS AS IT HAD TWO STIMULATING ELECTRODES AT 5.7 VOLTS. THE PATIENT WAS RECEIVING LIMITED THERAPY FROM THE INS UNTIL SHE COULD BE REIMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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