BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3790890 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08533
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ALARM FOR MOTOR STALL. IT WAS REPORTED THERE WAS HOSPITALIZATION, EXPLANT AND REPLACEMENT. IT WAS STATED THERE WAS INCREASED SPASTICITY. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION REPORTED THAT NO TESTS OR DIAGNOSTICS WERE PERFORMED. IT WAS NOTED THAT INTERROGATION OF THE PUMP INDICATED MOTOR STALL AND NO LOGS WERE AVAILABLE. IT WAS NOTED THE PATIENT WAS RECEIVING THERAPY AGAIN AND WAS WELL. THE PUMP WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE THERAPY DATE WAS REPORTED AS (B)(6) WITH ONSET OF (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267344 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Hospitalization| R