BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2715346 · Received August 27, 2012

    Report

    Report Number
    3004209178-2012-07393
    Event Type
    Injury
    Date Received
    August 27, 2012
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    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
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF INCREASED SPASTICITY. THE PUMP WAS FILLED WITH PRESERVATIVE-FREE SALINE SOLUTION AT IMPLANT AND KEPT ON MINIMUM RATE. ELEVEN DAYS LATER, THE PUMP WAS FILLED WITH BACLOFEN. TEN DAYS LATER THERE WAS AN ATTEMPT TO INCREASE THE DAILY DOSE, BUT THE EVENT LOGS SHOWED TELEMETRY WAS INTERRUPTED WHILE UPDATING THE PUMP. THE PUMP DID NOT 'FINISH' THE UPDATE CYCLE COMPLETELY, WHICH STOPPED THE PUMP. THREE DAYS LATER, A CRITICAL PUMP ALARM SOUNDED. INTERROGATION ON THAT DATE SHOWED THE PUMP WAS STOPPED FOR 79HRS:40MIN. THE PUMP WAS REACTIVATED ON MINIMAL RATE. THE PHYSICIAN OPTED TO KEEP THE PUMP AT MINIMUM RATE WHILE PATIENT WAS ON ORAL LIORESAL TABLETS. THE ORAL MEDICATION RELIEVED THE PATIENT'S INCREASED SPASTICITY. THE PATIENT WAS GOING TO BE ADMITTED TO THE HOSPITAL TO PERFORM A ROTOR TEST TO VALIDATE ROTOR FUNCTIONALITY. THE PUMP DAILY DOSE WAS GOING TO BE RAISED WHILE MONITORING THE PATIENT TO VALIDATE THE INTERNAL TUBE WAS NOT DAMAGED. LATER IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN TRIED PERFORMING THE ROLLER STUDY BUT WAS UNABLE TO SEE THE RADIOPAQUE MARKER. AS A RESULT THE STUDY COULD NOT BE COMPLETED. THE PATIENT WAS GOING TO BE HOSPITALIZED FOR 3 DAYS, SO THE PHYSICIAN SET THE PUMP TO 'SIMPLE CONTINUOUS' MODE AND WAS GOING TO CLOSELY MONITOR THE PATIENT IN THE HOSPITAL. THERE WAS NO PATIENT INJURY.

    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 00015 YR Hospitalization