BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2656538 · Received July 16, 2012

    Report

    Report Number
    3004209178-2012-05657
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Report Date
    June 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL # 8709SC, SERIAL # (B)(4), IMPLANTED ON: (B)(6) 2009, EXPLANTED ON: UNKNOWN. 8590-1 DACRON POUCH: LOT # N193633, IMPLANTED ON: (B)(6) 2009, EXPLANTED ON: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED WAS REPORTED. THE MOTOR STALL WAS CAUSED BY PATIENT HAVING MRI. THE HEALTH CARE PROVIDER REPORTED THE PATIENT HAD NO SYMPTOMS AND THIS WAS A PART OF THEIR YEARLY CHECK OF THE PATIENT. THE PUMP DELIVERED MORPHINE 5MG/ML AT 1.82MG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1