BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2816052 · Received November 1, 2012

    Report

    Report Number
    3004209178-2012-09854
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    July 16, 2012
    Report Date
    October 5, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V890309, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE "STOPPED WORKING" BASICALLY WHEN SHE MOVED ON (B)(6) 2012. THE PATIENT CHANGED TO PROGRAM 1 AT 2.9 VOLTS ON (B)(6) AND HAD HAD 1 TO 2 ACCIDENTS RECENTLY. IT WAS ALSO NOTED THAT THE PATIENT HAD THE DEVICE OFF, WAS ABLE TO DECREASE STIMULATION TO FEEL COMFORTABLE, AND WAS NOW ON PROGRAM 4 AT 1.8 VOLTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

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

    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