BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESYNCHROMED

    MDR report key: 914665 · Received September 14, 2007

    Report

    Report Number
    2182207-2007-02941
    Event Type
    Injury
    Date Received
    September 14, 2007
    Report Date
    August 20, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    [SEE SCANNED PAGES].

    Description of Event or Problem · 1

    CRUIKSHANK, ET AL. "INTRAVENOUS DIAZEPAM INFUSION IN THE MANAGEMENT OF PLANNED INTRATHECAL BACLOFEN WITHDRAWAL." DEVELOPMENTAL MEDICINE & CHILD NEUROLOGY. 2007; 49: 626-628. THE ARTICLE DESCRIBES AN 11 YEAR OLD FEMALE WITH CEREBRAL PALSY WITH DIPLEGIA WHO HAD A BACLOFEN PUMP IMPLANTED 3 YEARS PREVIOUSLY. SHE HAD A LONG HISTORY OF SKIN INFECTIONS OVERLYING THE PUMP WHICH REQUIRED REPOSITIONING ON SEVERAL OCCASIONS. TWO AND ONE HALF YEARS LATER, THE PUMP WAS REMOVED DUE TO INFECTION. ELEVEN MONTHS LATER, A NEW BACLOFEN PUMP WAS INSERTED. FIVE MONTHS LATER, A PERSISTENT WOUND INFECTION OVER HER LUMBAR SPINE RESULTED IN THE EXPOSURE OF THE UNDERLYING CATHETER. TO PREVENT FURTHER COMPLICATIONS, THE PUMP WAS REMOVED. PRIOR TO SURGERY, SHE WAS COMMENCED ON ORAL BACLOFEN. POST OP. SHE WAS COMMENCED ON A DIAZEPAM INFUSION WHICH WAS STOPPED AT 36 HOURS. SHE WAS THEN COMMENCED ON ORAL DIAZEPAM. SHE CONTINUED ON ORAL BACLOFEN POST OP. THE PROCEDURE AND POST OP COURSE WERE UNEVENTFUL. SHE DID NOT DEVELOP WORSENING SPASTICITY OR DYSTONIC SPASMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER| CATHETER: UNK