BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1068158 · Received July 1, 2008

    Report

    Report Number
    3004209178-2008-03691
    Event Type
    Injury
    Date Received
    July 1, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD GOOD THERAPEUTIC EFFECT UNTIL 2008, WHEN THE PT SHOWED SIGNS OF WITHDRAWAL WITH SYMPTOMS OF JERKING MOTIONS. THE HCP INCREASED THE ORAL BACLOFEN. AN X-RAY OF THE CATHETER WAS TAKEN, NO KINKS WERE APPARENT. THE NEX DAY, THE PT SHOWED SIGNS OF OVERDOSE SYMPTOMS INCLUDING LACK OF TONE, DROOLING AND POOR TRUNK CONTROL. THE ORAL BACLOFEN WAS DISCONTINUED. SUBSEQUENTLY, THE PT AGAIN PRESENTED WITH WITHDRAWAL SYMPTOMS OF JERKING MOTIONS. SIX DAYS LATER, A ROTOR STUDY WAS PERFORMED AND NO PROBLEMS WERE FOUND WITH THE PUMP. ANOTHER X-RAY WAS TAKEN WITH NO CATHETER KINKS OR DISCONNECTS NOTED. IT WAS SUSPECTED THAT INTERMITTENT KINKING WAS OCCURRING, POSSIBLY DUE TO DIFFERENT BODY POSITIONS. THE DOSE OF BACLOFEN 1000 MCG/ML ON THE SAME DAY, WAS 115 MICROGRAMS/DAY. THE PT UNDERWENT A CATHETER REVISION THE FOLLOWING MONTH. THE PROXIMAL SEGMENT OF THE CATHETER WAS REMOVED; ANOTHER CATHETER WAS SPLICED TO THE REMAINING SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention CATHETER MODEL # 8711 LOT#: J0058229R IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK