BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2211102 · Received August 8, 2011

    Report

    Report Number
    3007566237-2011-06141
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD RELOCATED AND NEEDED A REFILL. IT WAS ALSO NOTED THAT THE PUMP WAS "FAILING AND NEEDED TO BE REPLACED SOMETIME AS WELL". THE DRUGS INFUSED WERE DILAUDID AND BUPIVACAINE. PT COMPLAINTS INCLUDED, "SITTING IN THE CAR FOR LONG DISTANCES WAS REALLY HARD". IT WAS LATER REPORTED ON (B)(6) 2011 THAT A VOLUME DISCREPANCY HAD OCCURRED: ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. SPECIFIC VALUES FOR VOLUMES WERE NOT PROVIDED BUT IT WAS STATED THAT IT HAS BEEN HAPPENING FOR LAST FEW REFILLS: "RESIDUAL VOLUME HAS BEEN SLOWLY INCREASING OVER LAST FEW REFILLS". IN ADDITION, IT WAS NOTED THAT ONE OF THE REASONS FOR GETTING THE PUMP REPLACED WAS POSSIBLY RELATED TO BATTERY DEPLETION. RETURN OF SYMPTOMS, ESPECIALLY PAIN WAS ALSO REPORTED.

    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 EXPLANTED:| CATHETER: MODEL 8709, LOT# J0056602R| CATHETER: MODEL 8575, LOT# J12394R| EXPLANTED:| IMPLANTED:| IMPLANTED: