BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190937 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-05895
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL ALARM REGARDING A MOTOR STALL WAS HEARD; AND CONFIRMED BY TELEMETRY. MULTIPLE STALLS WERE INDICATED IN THE LOGS STARTING "BACK FROM LAST SUNDAY". IT WAS FURTHER NOTED THAT THE PT HAS HAD INTERMITTENT MOTOR STALLS AND RECOVERIES. THE LAST MOTOR STALL OCCURRED ON (B)(6) 2011, AND NO RECOVERY WAS SEEN. THE PT EXPERIENCED WITHDRAWAL; AND WAS ADMITTED TO A HOSPITAL. WHILE AWAITING A PUMP REPLACEMENT IN THE HOSPITAL, THE PT WAS ADMINISTERED ORAL BACLOFEN AND VALIUM. A PHYSICIAN HAD REDUCED THE DOSE TO 100 MCG/DAY IN CASE THE PUMP STARTED TO INFUSE. THE PUMP WAS REPLACED ON (B)(6) 2011. THE PUMP WAS USED TO DELIVER LIORESAL 2000 MCG/ML AT 509.6 MCG/DAY. ADDITIONAL INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    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 29 YR Hospitalization| R CATHETER: MODEL 8703W, LOT # L51797| EXPLANTED:| IMPLANTED: