BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1080192 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04217
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE DEVICE IS INCLUDED IN THE SYNCHROMED II MISSING PROPELLANT RECALL AND PHYSICIAN COMMUNICATION DATED 2008.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INCREASED SPASTICITY. THE PATIENT'S DOSE WAS INCREASED MANY TIMES, BUT THERE WASN'T ANY EFFECT. THE PUMP VOLUMES WERE CORRECT. THE PUMP WAS ON THE SERIAL NUMBER LIST FOR PUMPS MISSING PROPELLANT, SO THE HEALTH CARE PROFESSIONAL (HCP) REPLACED THE PUMP. THE PATIENT WAS REPORTED TO BE "OK" AFTER REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention