BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA RC

    MDR report key: 2241049 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06488
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE INS (B)(4) FOUND NO ANOMALIES. GOOD STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS. THE IPG WAS FUNCTIONALLY OK. ANALYSIS OF THE INS (B)(4) FOUND NO ANOMALIES. GOOD STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS. THE IPG WAS FUNCTIONALLY OK. ANALYSIS OF THE INS (B)(4) FOUND NO ANOMALIES. GOOD STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS. THE IPG WAS FUNCTIONALLY OK. ANALYSIS OF THE INS (B)(4) FOUND NO ANOMALIES. GOOD STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND...

    Description of Event or Problem · 1

    THE PT HAD AN IMPLANTED DBS SYSTEM INCLUDING BILATERAL 3389S-40 LEADS, BILATERAL (B)(4) EXTENSIONS AND AN ACTIVA PC (B)(4) PRIOR TO PROCEDURE. ELECTRODE CONFIGURATION WAS SET AT 2X4 WITH CHANNEL 1 SET AT 0-3 AND CHANNEL 2 SET AT 8-11 TO ACCOMMODATE BILATERAL EXTENSIONS. THIS ELECTRODE CONFIGURATION WAS USED DURING ALL TESTING. THE ACTIVA PC WAS PLANNED TO BE REPLACED WITH AN ACTIVA RC (B)(4). ELECTRODE IMPEDANCES WERE TESTED PRIOR TO THE BEGINNING OF THE PROCEDURE WITH NO ABNORMALITIES FOUND. THE REPLACEMENT IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED AND CHARGED WHILE IN THE BOX PRIOR TO THE CASE. THE ACTIVA PC WAS DISCONNECTED FROM THE EXTENSIONS USING THE SCREWDRIVER PROVIDED WITH THE INS. THE EXTENSIONS WERE INSERTED INTO THE CORRECT PORTS OF THE NEW RC. ELECTRODE IMPEDANCES WERE CHECKED AT THAT TIME WITH THE INS IN THE POCKET. IMPEDANCES MEASURED ABOVE 40,000 OHMS FOR MULTIPLE ELECTRODE PAIRS. MULTIPLE ATTEMPTS AT REINSERTING THE EXTENSIONS CONTINUED TO YIELD HIGH IMPEDANCES. A SECOND ACTIVA RC (B)(4) WAS OPENED. THE EXTENSIONS WERE VISUALLY EXAMINED AND NO VISUAL DAMAGE TO THE EXTENSIONS COULD BE NOTED. REPEATED IMPEDANCE TESTING WITH THE 2ND RC PROVIDED RESULTS MATCHING THOSE NOTED ABOVE WITH THE 1ST RC. THE EXTENSIONS WERE CONNECTED TO THE EXPLANTED PC, WHICH REMAINED UNCONTAMINATED ON THE STERILE FIELD, AND IMPEDANCE TESTING PROVIDED NORMAL RESULTS. THE (B)(4) ALLIGATOR CLIPS WERE USED TO TEST BOTH EXTENSIONS ON ELECTRODE PAIRS THAT HAD BEEN SHOWING IMPEDANCES >40000. THE TESTS REVEALED NORMAL IMPEDANCE VALUES FOR THOSE PAIRS. ALL IMPEDANCE TESTING, THROUGHOUT, WAS PERFORMED WITH THE INS IN THE POCKET. THE (B)(4) WERE TESTED TO RULE OUT THE POSSIBILITY OF A PROBLEM WITH THE (B)(4) BUT THERE WAS NO CHANGE IN RESULTS USING THE NEW (B)(4). A NEW ACTIVA PC (B)(4) WAS OPENED AND CONNECTED, BUT TESTING WAS UNABLE TO ACHIEVE IMPEDANCE VALUES THAT DIFFERED FROM WHAT HAD BEEN SEEN WITH THE 2 RCS. A FINAL ACTIVA RC (B)(4) WAS OPENED AND CONNECTED. IMPEDANCE TESTING PROVIDED NORMAL VALUES FOR ALL ELECTRODE PAIRS IN CHANNEL 1. CHANNEL 2 CONTINUED TO SHOW IMPEDANCES ABOVE 40,000 OHMS EXCEPT FOR CASE AND 8. THIS INS WAS IMPLANTED. CHANNEL 1 WAS PROGRAMMED TO THE PT'S PREVIOUS SETTINGS AND CHANNEL 2 WAS PROGRAMMED AROUND THE HIGH IMPEDANCES. IT WAS REPORTED THAT THE PT WAS RECEIVING EFFECTIVE THERAPY. REFER TO MFR REPORT #3004209178201106489, 3004209178201106492, 3004209178201106493.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA RC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37612 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37612,| EXPLANTED:| LOT# NKM704846H| LOT# NKM707229H| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37601,| LOT# NKG702830H| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN009209V| LEAD: MODEL 3389S-40, LOT# V475905| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN009125V| IMPLANTABLE NEURO STIMULATOR: MODEL 37601,| EXPLANTED:| IMPLANTED:| IMPLANTED NEURO STIMULATOR: MODEL 37612,| PROGRAMMER: MODEL 37642, LOT# NJZ105085N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NKG702941H| IMPLANTED: