BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2181603 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05207
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    February 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE PUMP REPORTED S2 CORROSION AND/OR MECHANICAL WEAR. RESIDUE WAS SEEN ON THE PINION OF GEAR 1 AND 2 AND THE UPPER SHAFT OF GEAR 3 AND ON THE TOP AND BOTTOM SIDE OF THE PUMPHEAD. PERTINENT PUMP LOG SHOWED MOTOR STALL AND MOTOR STALL RECOVERY. NO STALLS OCCURRED DURING TESTING. FINAL ANALYSIS OF THE CATHETER REPORTED A PUMP CONNECTOR ANOMALY. THERE WAS A SMALL CAVITY OF UNKNOWN ORIGIN IN THE SILICONE MATERIAL OF THE PUMP CONNECTOR. NO LEAKING WAS SEEN IN THE AREA OF THIS CAVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "EVERY TIME THEY REFILLED THE PATIENT'S PUMP, THE VOLUMES WITHDRAWN WERE ALWAYS AT LEAST 15% GREATER THAN WHAT THE PROGRAMMER SHOWED AFTER INTERROGATION." THE PATIENT HAD NO ADVERSE EFFECTS. THE PHYSICIAN WAS CONCERNED THAT "THE DEVICE WOULD EVENTUALLY NOT WORK" AND THE PUMP WAS REPLACED. THE PATIENT WAS STARTED ON LIORESAL 2000MCG/ML AT 900MCG/DAY, ABOUT A 22% DECREASE FROM THE AMOUNT THAT HE WAS PREVIOUSLY ON.

    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 32 YR Required Intervention CATHETER: MODEL 8709, LOT# L81294| EXPLANTED:| IMPLANTED: