BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1970151 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00406
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE PT'S PUMP REPLACEMENT (SEE MFR'S REPORT #6000030-2011-00405 FOR PUMP REPLACEMENT DUE TO DISCONNECT), THE PT'S NECK PAIN "HAS GONE FROM 0 TO ABOUT A 4." A CATHETER DYE STUDY WAS DONE IN WHICH THE PT REC'D A BOLUS DOSE AND RHIZOLYSIS HAD ONLY A SECOND OR TWO OF "A STRANGE WEAK FEELING". THE PT WAS PLACED ON LIFE SUPPORT FOLLOWING THAT EVENT. THE PT STATED THAT "HAD I NOT BEEN IN DAY SURGERY RECOVERY, I WOULD HAVE DIED." A YR LATER, THE PT'S PAIN SPECIALIST TOLD THE PT THAT THE "PAIN THERAPY WAS PRIMARILY FOR LOWER LIMB SPASTICITY AND WASN'T EFFECTIVE FOR CERVICAL DYSTONIA." WHEN THE PT'S DOSAGE WAS REDUCED, SHE EXPERIENCED SEVERE BODY SPASMS. ONCE THE DOSE WAS TITRATED UP, THE NECK SPASMS WERE UNCHANGED. THE PT WAS GIVEN "BOTOX B" BUT SHE STATED THAT SHE HAD "DEVELOPED ANTIBODIES TO THAT. HAD I KNOWN WHAT I KNOW NOW ABOUT THE DEPENDENCY MY BODY WOULD DEVELOP TO BACLOFEN, I NEVER WOULD HAVE SELECTED THAT OPTION." THE PT STARTED TO SEE A NEUROSURGEON THAT SPECIALIZED IN DENERVATION PROCEDURES. FOUR PERIPHERAL AND RHIZOLYSIS PROCEDURES LATER, THE NECK TWISTING WAS MINIMAL BUT THE TIGHTNESS REMAINED. HER LEFT STERNO-ADRENAL MUSCLE HAD ATROPHIED. THE MEDICATION IN THE PUMP WAS LIORESAL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R CATHETER: MODEL 8709, LOT# L78004| IMPLANTED:| EXPLANTED: