BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2182311 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05266
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PUMP MOTOR STALL WAS REPORTED AND CONFIRMED ON EVENT LOGS WITH NO MOTOR STALL RECOVERY. A ROTOR DYE STUDY WAS PERFORMED BUT WAS ABORTED DUE TO DIFFICULTY IN ACCESSING THE PUMP AND PT DISCOMFORT. IT WAS LATER REPORTED THAT THE PUMP DID RECOVER BUT STALLED AGAIN. ON INTERROGATION, THE LOGS INDICATED THREE SEPARATE STALLS WITH RECOVERY AT THE LAST STALL AS PER LOGS. THE PT REPORTED RETURN OF SYMPTOMS, "WITHDRAWAL". PUMP REPLACEMENT WAS TO BE SCHEDULED. THE PUMP INFUSED MORPHINE, 8MG/ML CONCENTRATION, DOSE 2.4993/DAY. A F/U REPORT WILL BE SENT, IF ADD'L INFO IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT #N187488003| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT #N175919015