BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2223864 · Received August 18, 2011

    Report

    Report Number
    3007566237-2011-06544
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS BEING REPLACED DUE TO AN ERI (ELECTIVE REPLACEMENT INDICATOR). DURING REPLACEMENT, A LEAK IN THE CATHETER NEAR THE PUMP WAS NOTED. "UPON OPENING THE PUMP SOCKET IT WAS DISCOVERED THAT HER CATHETER LAY DIRECTLY OVER THE PUMP REFILL SEPTUM AND HAD BEEN PUNCTURED NUMEROUS TIMES MOST LIKELY BY THE REFILL NEEDLE." THE PUMP INFUSED LIORESAL 2000, AT 466.5 DAILY DOSE. THE PHYSICIAN TURNED THE DOSE DOWN TO 400 MCG/DAY CONSIDERING THE POSSIBILITY OF AN OVERDOSE OR WITHDRAWAL. PT EXPERIENCED NO SYMPTOMS. FOLLOWING THE SURGERY, THE PT WAS FINE AND REPORTED NO ADVERSE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention CATHETER: MODEL 8731, LOT# B011785N25| IMPLANTED:| EXPLANTED: