BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242966 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-07659
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS RESULTS REVEALED THE AA BATTERIES IN THE PROGRAMMER WERE AT 1/2 POWER WHEN TESTING WAS STARTED. AFTER 5-7 MINUTES INTO TESTING THE BATTERY, LEVEL WAS DOWN TO 1/4 POWER. IT WAS SUSPECTED THE PROBLEM MAY HAVE BEEN RELATED TO THE BATTERIES. THE PROGRAMMER WAS ABLE TO READ AND UPDATE ANOTHER PUMP. ANALYSIS WAS UNABLE TO DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SHUT OFF DURING THE UPDATE OF THE PUMP AFTER A REFILL. THE HCP SHUT OFF THE PROGRAMMER AND ATTEMPTED TO UPDATE AGAIN. AFTER RESTARTING, THE PROGRAMMER SHOWED THE PUMP HAD BEEN OFF FOR 1 MINUTE. THE PATIENT WAS SENT HOME. THE FOLLOWING DAY, THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS OF; INCREASED BASELINE SPASTICITY, INCREASED RIGIDITY, TACHYCARDIA, CLONUS, REBOUND SPASTICITY, AND WAS PALE AND CLAMMY. UPON INTERROGATION OF THE PUMP, IT WAS NOTED THE PUMP HAD BEEN OFF FOR 18 HOURS DUE TO THE PUMP GOING INTO STOPPED PUMP MODE AFTER THE PROGRAMMER SHUT OFF THE PREVIOUS DAY. THE PUMP WAS UPDATED; THE PATIENT WAS GIVEN A THERAPEUTIC BOLUS OF 100 MCG/ 20 MINUTES AND SENT TO THE EMERGENCY ROOM FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8711| PROGRAMMER: MODEL 8840