BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1884840 · Received October 15, 2010

    Report

    Report Number
    3007566237-2010-08017
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    May 30, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S PUMP HAD INTERMITTENT MOTOR STALLS. THE PATIENT EXPERIENCED WITHDRAWAL IN ADDITION TO NAUSEA, SWEATING, AND A RETURN OF PAIN. THE PATIENT HAD VISITED AN ER, AND WAS TOLD THE PAIN WAS DUE TO CONSTIPATION. THE PATIENT WAS HEARING A TWO TONE ALARM EVERY HOUR BEGINNING 2 WEEKS AGO. THE STALL WAS CONFIRMED IN THE EVENT LOGS, WITH NO MOTOR STALL RECOVERY RECORDED. SEVERAL STALLS AND RECOVERIES (B)(6) WERE NOTED. IN ADDITION, MOTOR STALLS/RECOVERIES HAD OCCURRED ON THE FOLLOWING DATES AND TIMES: (B)(6) 2010 AT 12:40 WITH RECOVERY AT 13:39, (B)(6) 2010 AT 13:12 WITH RECOVERY ON (B)(6) 2010 AT 3:41, AND ON (B)(6) 2010 AT 22:56 WITH RECOVERY ON (B)(6) 2010 AT 22:56. AFTER (B)(6), THE PUMP HAD NOT RECOVERED, AND A TUBE SET ALARM OCCURRED. THE PATIENT VISITED A PHYSICIAN ON (B)(6) 2010 AND TELEMETRY HAD SHOWED THAT THE PUMP HAD BEEN SHUTTING OFF SINCE (B)(6) 2010, AND HAD ALSO BEEN OFF FOR FIVE DAYS. THE PUMP WAS NOTED TO HAVE HAD TURNED BACK ON AGAIN ON (B)(6) 2010. AT THE LAST PUMP REFILL WHICH OCCURRED 2 MONTHS FROM (B)(6) 2010, THE BATTERY LIFE WAS DETERMINED TO BE ONE YEAR. THE BATTERY LIFE WAS NOW SHOWING 6 MONTHS IN (B)(6). A PUMP REPLACEMENT WAS PLANNED. THE MEDICATION ADMINISTERED VIA THE PUMP WAS FENTANYL (750 MCG/ML AT 46.79 MCG/HR) AND BUPIVACAINE (30 MG/ML AT 1.872 MG/HR). ORAL MEDICATION WAS BEING USED TO SUPPORT THE PATIENT UNTIL THE PUMP REPLACEMENT OCCURRED. ADDITIONAL INFORMATION IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# B010117N32