BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2003696 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01397
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (POPPING NOISE). THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HEARD AN INTERMITTENT "POPPING SOUND" COMING FROM THE PUMP. THE PT WAS STILL RECEIVING ADEQUATE THERAPY FROM THE IMPLANTED DEVICE, DESPITE THE NOISE THAT WAS NOTED. THERE WERE NO PUMP ALARMS PRESENT. THE SOUND WAS LATER HEARD BY THE HCP AND THE STAFF IN THE OPERATING ROOM AT THE PUMP EXPLANT PROCEDURE UNTIL THE VOLUME OF MEDICATION WAS REMOVED FROM THE PUMP RESERVOIR (5ML); THE POPPING SOUND THEN CEASED. THE PT DID NOT EXPERIENCED SYMPTOMS. THE PUMP WAS REPLACED AND THE ACTUAL RESIDUAL VOLUME WAS 5.0ML AND THE EXPECTED RESIDUAL AMOUNT WAS 3.3ML WHICH WAS WITHIN NORMAL LIMITS. THE PT WAS REPORTED TO BE "DOING WELL" AND RECOVERED WITH OUT SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention CATHETER: MODEL 8709, LOT# J11453R05| IMPLANTED:| CATHETER: MODEL 8578, LOT# N137745| EXPLANTED:| IMPLANTED:| EXPLANTED: