BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2875191 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11889
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    8731SC SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: UNKNOWN. (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

    FINAL ANALYSIS OF THE PUMP FOUND MULTIPLE MOTOR STALLS AND RECOVERIES IN THE LOGS. DURING DESTRUCTIVE ANALYSIS, THE TECHNICIAN FOUND BRIDGING ACROSS THE INSULATION OF THE M2 FEED-THRU. THIS MAY BE THE CAUSE OF THE MOTOR STALLS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT HEARD WHAT SOUNDED LIKE A CRITICAL ALARM. THE PATIENT WAS NOT DUE FOR A REFILL. THE PATIENT DID NOT HAVE AN INCREASE IN PAIN BUT DID HAVE SOME DIARRHEA AND VOMITING THAT THE PATIENT REPORTED HAVING ONCE EVERY FEW MONTHS. THE PATIENT ALSO REPORTED FEELING JITTERY, NERVOUS AND SWEATY SINCE STARTING TO HEAR THE ALARM. IT WAS FURTHER REPORTED THAT THE PUMP WAS STALLING AND THEN RECOVERING; OVER 10 TIMES IN 3 DAYS. A PUMP REPLACEMENT WAS PLANNED. THE PUMP WAS PUT IN MIN RATE MODE AND THE PATIENT WAS MANAGED BY ORAL MEDICATION. THE PUMP WAS REPLACED (B)(6) 2012. THERE WAS NO INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention