BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3220907 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11616
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    April 22, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA01FG5, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT AT AN APPOINTMENT ON (B)(6) 2013 THE PATIENT WAS INFORMED BY THE MANUFACTURER REPRESENTATIVE THAT SHE HAD A "BROKE LEAD WIRE." TWO DAYS LATER IT WAS REPORTED THAT "ONE OF THE WIRES WAS BROKEN." THE PATIENT ALSO STATED THAT SHE MET A DIFFERENT MANUFACTURE REPRESENTATIVE "ONE TO TWO MONTHS AGO" AND THOUGHT SHE HAD A "BENT WIRE." ABOUT TWO AND A HALF WEEKS LATER IT WAS REPORTED THAT THE FIRST MANUFACTURER REPRESENTATIVE HAD BEEN DEALING WITH THE ISSUE BUT IT WAS UNKNOWN WHAT THE EXACT DATE WAS THAT HE FIRST KNEW ABOUT IT. THE PATIENT'S LEAD FRACTURE WAS DUE TO A FALL BUT THE DEVICE STILL WORKED DEPENDING ON THE PATIENT'S POSITION. THE PATIENT HAD OTHER NEUROLOGIC ISSUES THAT CAUSED HER TO FALL. THE PATIENT WAS PROGRAMMED "AWAY" FORM THE ELECTRODE THAT DID NOT WORK. THE HEALTH CARE PROVIDER (HCP) WANTED TO EXTEND THE DEVICE'S LIFE AS LONG AS POSSIBLE BUT THE PATIENT NEEDED A REVISION "SOON." THE SECOND MANUFACTURER REPRESENTATIVE WAS MEETING THE PATIENT THE DAY AFTER THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT UPON ANALYSIS OF THE DEVICE WITH THE CLINICIAN PROGRAMMER EVERY ELECTRODE IN THE PATIENT'S LEAD WAS WORKING. IT WAS NOTED THAT THE PATIENT HAD SEVERAL FALLS AND TRAUMA EVENTS AND THE HEALTH CARE PROVIDER'S (HCP'S) OPINION WAS THAT THE FALLS WERE THE REASON FOR THE LACK OF DEVICE EFFICACY. IT WAS REPORTED THAT THE DEVICE WAS WORKING PROPERLY AND THE MANUFACTURER REPRESENTATIVE COULD PROVIDE DOCUMENTATION TO SUPPORT THAT THERE WAS NO BROKEN WIRE. THE HCP WAS EVALUATING WHETHER THE PATIENT REQUIRED ANY KIND OF REVISION SURGERY AS THEY WERE HAVING AN ARRAY OF OTHER MEDICAL COMPLICATIONS THAT FAR EXCEEDED THE DEVICE. IT WAS NOTED THAT THE HCP WAS ALSO EVALUATING IF THEY SHOULD ORDER AN X-RAY OF THE DEVICE TO VERIFY PLACEMENT OF THE LEAD OR ANY MIGRATION THAT MAY HAVE OCCURED DUE TO THE PATIENT'S SERIOUS OF TRAUMATIC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319413 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1