BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2212655 · Received August 11, 2011

    Report

    Report Number
    3004209178-2011-06252
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P80004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CSF LEAK. THE PATIENT HAD NUMBNESS AND WEAKNESS IN THE LEGS. THE NUMB AREAS HAD TURNED TO A BURNING FEELING. THE PATIENT HAD PROBLEMS SINCE THE PUMP WAS REPLACED. THE PATIENT HAD A LUMP OF FLUID NEAR THE DEVICE AFTER THE REPLACEMENT THAT WENT AWAY AND CAME BACK. THE PATIENT THOUGHT THEY MIGHT HAVE HAD AN INFECTION. THE PATIENT REPORTED THAT HER DOCTOR TOLD HER SHE WAS ON "FOUR TIMES THE AMOUNT OF BUPIVICAINE" THAT HE HAD EVER SEEN A PATIENT ON. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS BUPIVICAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other CATHETER: MODEL 8578, LOT # N193015022| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8832, LOT # NJG005526N| EXPLANTED:| CATHETER: MODEL 8709, LOT # N194604012| EXPLANTED:| IMPLANTED: