BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2003749 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01388
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 8, 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
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NOTICED AN ALARM FROM THE PUMP AT THE BEGINNING OF (B)(6) 2011 AND EXPERIENCED ITCHING AND INCREASED SPASTICITY. PUMP INTERROGATION WAS DONE AT THIS TIME AND THIS CONFIRMED A MOTOR STALL IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE PATIENT DENIED EXPOSURE TO ANY MAGNETIC OR EMI (ELECTROMAGNETIC INTERFERENCE) SOURCES. IT WAS LATER REPORTED ON (B)(6) 2011, THE PUMP STALL RECOVERED; HOWEVER, THE PATIENT HAD THE PUMP REPLACED WITHIN THE "PAST COUPLE OF DAYS." THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention