BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2961877 · Received February 14, 2013

    Report

    Report Number
    3007566237-2013-00483
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A PUMP MOTOR GEAR TRAIN ANOMALY OF CORROSION AND-OR WEAR AND-OR LUBRICATION. ANALYSIS OF THE CATHETER REVEALED ACCEPTABLE CATHETER TESTING. IT WAS NOTED THAT AN INCOMPLETE CATHETER WAS RETURNED. THE CATHETER WAS RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE PATIENT WENT TO THEIR CLINIC, THE LOGS WERE READ, AND THERE WAS A MOTOR STALL. IT RESTARTED AND THEN STALLED AGAIN. THE TIMES OF THE STALLS CORRELATED WITH THE PATIENT'S WITHDRAWAL SYMPTOMS. THERE WAS ALSO UNDERDOSE SYMPTOMS NOTED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A MAGNETIC RESONANCE IMAGING (MRI) STUDY. THE PUMP WAS TURNED TO MINIMAL FLOW RATE, AND THE PATIENT WAS TREATED WITH ORAL OPIOIDS. THE PUMP WAS PROPHYLACTICALLY EXPLANTED AND REPLACED TO AVOID IN-VIVO BATTERY DEPLETION. THE PATIENT RECOVERED WITHOUT SEQUELA. OF NOTE, THE PATIENT LOG SHOWED THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 2 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MOTOR STALL AND THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. THE PATIENT HAD CALLED HIS HEALTHCARE PROVIDER INDICATING HE HAD HEARD HIS PUMP ALARM 2 DAYS BEFORE AND THEN STARTED HAVING WITHDRAWAL SYMPTOMS. HIS PUMP ELECTIVE REPLACEMENT INDICATOR (ERI) WAS 3 MONTHS. THE PATIENT WAS PROGRAMMED TO A MINIMUM FLOW RATE ON (B)(6) 2013, PLACED ON ORALS AND IS TO HAVE THE PUMP REPLACEMENT SURGERY ON (B)(6) 2013. THE MEDICATIONS BEING DELIVERED WERE MORPHINE AND FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64975 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention