BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2936250 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01166
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V875083, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS NOT ABLE TO URINATE, WHICH STARTED THE DAY OF THE REPORT ABOUT TWO HOURS PRIOR TO THE REPORT. THE REPORTER STATED THAT THE PATIENT HAD A RETURN OF URINARY RETENTION AND THAT SHE HAD TO USE A CATHETER. IT WAS NOTED THAT THE REASON THAT THE PATIENT HAD THE DEVICE WAS TO EMPTY THE BLADDER. THE PATIENT WAS ON PROGRAM TWO AT 1.85 VOLTS. IT WAS REPORTED THAT IF THE DEVICE DID NOT HELP THE PATIENT SHE WOULD GO TO THE EMERGENCY ROOM. THE REPORTER STATED THAT THE PATIENT HAD NO STIMULATION SENSATION. 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
    40264 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR