BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2683037 · Received August 6, 2012

    Report

    Report Number
    3004209178-2012-06510
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Report Date
    July 10, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4),: PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING NO STIMULATION SENSATION. THE PATIENT HAD LOSS OF BLADDER CONTROL, WHICH STARTED FOLLOWING THE IMPLANT. THE PATIENT DID FEEL STIMULATION DURING THE TRIAL. IT WAS ALSO REPORTED THAT WHEN INCREASED STIMULATION FROM 1.1 TO 1.6, COMMUNICATION BETWEEN THE DEVICE AND THE PROGRAMMER WAS LOST. THERE WAS NO SWELLING OR BANDAGES PRESENT, BUT THE PATIENT WAS UNABLE TO SYNC WITH THE DEVICE AGAIN. THE PATIENT FELL THIS WEEK AND HAD AN APPOINTMENT WITH HER PHYSICIAN THIS AFTERNOON. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELL SECONDARY TO HER VERTIGO. NO ABNORMAL IMPEDANCES WERE REPORTED. THERE WAS REPROGRAMMING AND INCREASED INTENSITY BY LESS THAN 1. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1