BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2863363 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11332
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. LATE MDR SUBMISSION DUE TO SYSTEM ISSUE WITH FDA.

    Additional Manufacturer Narrative · 1

    EVAL - RESULT - UNK WRENCH ACCESSORY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) FOUND THAT THE SETSCREW WAS BACKED OUT TOO FAR AND FORCED INTO THE TECOTHANE. SMALL CHIPS OF THE TECOTHANE MATERIAL HAVE BEEN CUT FREE BY THE SET SCREW. THE SET SCREW TIGHTENED PROPERLY TO THE LEAD DURING TESTING. THE SET SCREW WAS STILL ENGAGED IN SET SCREW BLOCK THREADS. A KNOWN GOOD LEAD WAS COMPLETELY INSERTED INTO THE INS PORT AND THE SETSCREW WAS TIGHTENED DOWN ONTO THE LEAD USING THE RETURNED TORQUE WRENCH. THE LEAD HELD SECURELY IN PLACE. THE INS OUTPUT WAS TESTED AT THE DISTAL END OF THE LEAD. STABLE OUTPUT WAS OBSERVED ON EACH PROGRAM AS RECEIVED ON AN OSCILLOSCOPE. EACH CIRCUIT WAS TESTED IN REFERENCE TO THE CAS ELECTRODE ON AN OSCILLOSCOPE WITH GOOD STABLE OUTPUT OBSERVED. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. ANALYSIS OF THE UNKNOWN WRENCH ACCESSORY FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_WRENCH_ACC, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD CONNECTION TO BATTERY WAS FAULTY. IT WAS NOT NORMAL BATTERY DEPLETION. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INJURY OR DEATH AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) IMPLANTED THE DEVICE AND TIGHTENED THE SETSCREW UNTIL IT CLICKED. WHEN THE HCP REPOSITIONED THE DEVICE TO COMMUNICATE WITH THE PHYSICIAN PROGRAMMER THE LEAD CAME LOOSE. THE HCP WAS UNABLE TO TIGHTEN THE SCREW ON TO THE LEAD EVEN THOUGH THEY HEARD THE CLICKS. A SECOND DEVICE WAS USED AND "WORKED FINE." IT WAS NOTED THAT THE PATIENT IS "DOING FINE." THE FOLLOWING DAY IT WAS REPORTED THAT THERE WAS NOT A KNOWN CAUSE OF THE EVENT. THE DEVICE WAS REPORTEDLY PULLED OUT OF THE POCKET BECAUSE THE PHYSICIAN PROGRAMMER WAS NOT "PICKING UP" THE DEVICE. WHEN THE HCP MOVED THE DEVICE THE LEAD REPORTEDLY "FELL OUT." THE HCP ATTEMPTED TO REPLACE THE LEAD AND TURN THE SET SCREW MULTIPLE TIMES BUT IT NEVER WORKED CORRECTLY. A SECOND DEVICE WAS USED AND WORKED FINE. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    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