BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 884804 · Received July 24, 2007

    Report

    Report Number
    2182207-2007-02314
    Event Type
    Injury
    Date Received
    July 24, 2007
    Report Date
    May 12, 2005
    Manufacturer
    NEUROLOGICAL DIVISION, MEDTRONIC INC
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE ADDITIONAL SCANNED PAGES.

    Description of Event or Problem · 1

    TAHA J ET AL. "CORRELATION BETWEEN WITHDRAWAL SYMPTOMS AND MEDICATION PUMP RESIDUAL VOLUME IN PTS WITH IMPLANTABLE SYNCHROMED PUMPS" NEUROSURGERY. 2004; 55, 2: 390-393. EIGHTY EIGHT PTS FOLLOWED BY THE AUTHOR UNDERWENT IMPLANTATION OF A SYNCHROMED PUMP BY TWO NEUROSURGEONS FOR THE TREATMENT OF CHRONIC PAIN OR SPASTICITY. TWENTY-FOUR PERCENT OF THE PTS CONSISTENTLY DEVELOPED SYMPTOMS OF DRUG WITHDRAWAL 1-7 DAYS BEFORE THE DRUG RESIDUAL VOLUME REACHED A MEAN OF 2.7 ML. SYMPTOMS FIRST DEVELOPED 1-18 MONTHS AFTER SURGERY. IN ALL PTS, THE SYMPTOMS OF DRUG WITHDRAWAL SUBSIDED AFTER A PUMP REFILL AND DID NOT RECUR AFTER THE ALARM VOLUME WAS INCREASED TO 4 ML. THE CONCLUSION WAS THAT SOME PTS DEVELOP SYMPTOMS OF DRUG WITHDRAWAL AT RESIDUAL VOLUMES THAT EXCEED 2 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK NEUROLOGICAL DIVISION, MEDTRONIC INC PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK| EXPLANTED| CATHETER MODEL CATHETER LOT UNK| IMPLANTED| EXPLANTED