BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2936033 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01149
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 12, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V749365, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN HAVING SPASMS FOR "ONE YEAR OR SO." IT WAS STATED THE PATIENT FELT A SHOCKING SENSATION AS WELL. THE DEVICE WAS TURNED OFF. IT WAS INDICATED THE PATIENT HAD AN APPOINTMENT WITH THEIR DOCTOR ON THE FOLLOWING MONDAY, AS OF THE DATE OF THIS REPORT. IT WAS ADDITIONALLY NOTED THE PATIENT HAD INTERSTIAL CYSTITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40428 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1