BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2181279 · Received July 21, 2011

    Report

    Report Number
    3007566237-2011-05633
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVERDOSE HAD OCCURRED DURING A REFILL SESSION. IT WAS NOT KNOWN IF THE OVERDOSE HAD CAUSED A PROBLEM. THE PT WAS PUT ON A NARCAN DRIP FOLLOWING THE OVERDOSE AND SENT TO HER HEALTH CARE PROVIDER FOR REPROGRAMMING. A BRIDGE BOLUS WAS PROGRAMMED, BUT NO PROGRAMMING ERRORS WERE FOUND. WHEN THE PT ARRIVED AT THE HEALTH CARE PROVIDER'S OFFICE, THE BRIDGE WAS ONE HOUR FROM COMPLETION. THE HEALTH CARE PROVIDER CANCELLED THE BOLUS AND LOWERED THE PROGRAM RATE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N184832019| IMPLANTED:| EXPLANTED: