BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2828036 · Received November 12, 2012

    Report

    Report Number
    3004209178-2012-10122
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Report Date
    October 15, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V973942, IMPLANTED: (B)(6) 2012, 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 SINCE YESTERDAY WHENEVER THE PATIENT WOULD MOVE, SHE WAS EXPERIENCING PAIN IN THE AREA THAT SURROUNDS THE LEAD. WHEN SHE LOOKED AROUND THE AREA, IT WAS NOT RED; IT WAS RED WHERE THE BATTERY WAS BECAUSE OF THE STITCHES. THE PATIENT STATED IT WAS HEALED BACK THERE, FELT LIKE A LITTLE BALL AND THOUGHT THAT WAS WHERE IT CLOSED UP, AND IT WAS NOT THERE BEFORE. IT JUST DID NOT FEEL RIGHT AND WHEN THE NURSE CALLED HER BACK THE NURSE PRACTITIONER WAS GONE FOR THE DAY AND WOULD GIVE AN UPDATE TO THE HCP (HEALTH CARE PROFESSIONAL) TOMORROW. THE PATIENT DID HAVE A TODDLER, BUT HAD NOT BEEN PICKING HIM UP. IT WAS NOTED THAT THE PATIENT WAS ON PROGRAM 2 AT 2.0 VOLTS AND THE DEVICE WAS ON. SINCE SHE GOT THE IMPLANT, THE PATIENT WAS GOING MORE AND THOUGHT SHE SHOULD TURN IT UP, BUT DIDN¿T WANT TO MESS WITH IT BECAUSE IT SEEMED COMPLICATED. THE PATIENT ADJUSTED STIMULATION UP TO 2.3 VOLTS AND COULD FEEL IT THEN TURNED IT BACK DOWN TO 2.2 VOLTS AND THEN BACK UP TO 2.3 VOLTS. DURING THE TRIAL SHE USED BETWEEN 1-2 VOLTS AND SOMETIMES DIDN'T LEAK, MAYBE ONCE A DAY, AND COULD MAKE IT ALL THE WAY HOME, BUT WITH THE PERMANENT IMPLANT THE PATIENT WAS BACK TO LEAKING 2-3 TIMES A DAY AND WAS STILL WEARING PADS. THE PATIENT WAS HAVING DIFFICULTY OPERATING THE PROGRAMMER DUE TO ITS COMPLEXITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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