BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2933235 · Received January 29, 2013

    Report

    Report Number
    3007566237-2013-00305
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 8703, LOT# J89062329, IMPLANTED: (B)(6) 1989, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A BRIDGE BOLUS (BB) WAS INCORRECTLY PERFORMED. A PUMP REFILL AND CONCENTRATION CHANGE FROM 2000 MCG/ML TO 500 MCG/ML WAS PROGRAMMED. A RESERVOIR RINSE HAD BEEN DONE. THE PATIENT EXPERIENCED POSSIBLE OVERDOSE SYMPTOMS. THE OLD DRUG DESIRED DOSE FOR THE BB WAS SUPPOSED TO BE 260 MCG BUT 500 MCG WAS PROGRAMMED. THE PATIENT RETURNED TO THE CLINIC THE FOLLOWING DAY. APPROXIMATELY 26 HOURS HAD PASSED SINCE THE UPDATE. THE BRIDGE BOLUS WAS CANCELED AND THE PUMP WAS UPDATED. THE PUMP WAS PROGRAMMED TO RUN THE DRUG AT 260MCG PER DAY RATE. THE PUMP WAS DELIVERING GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD BEEN MAINLY LETHARGIC. THE PATIENT WAS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38788 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other