BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971600 · Received January 25, 2011

    Report

    Report Number
    3004209178-2011-00599
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 1, 2009
    Report Date
    January 18, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SHORTLY AFTER THE INITIAL IMPLANT, THE PUMP CAME LOOSE AND THE CATHETER WAS TWISTED AND KINKED. THE PT WAS NOT RECEIVING BACLOFEN, SO IN (B)(6) 2009 SURGERY WAS DONE TO REATTACH THE PUMP. IN (B)(6) 2010, THE PUMP WAS LOOSE AGAIN AND THE CATHETER WAS KNOTTED AND ONCE AGAIN THE PT WAS NOT RECEIVING ANY BACLOFEN, SO A THIRD SURGERY WAS NEEDED TO REATTACH THE PUMP. IN (B)(6) 2010, THE PT WAS PRETTY SURE SHE WAS NO LONGER RECEIVING BACLOFEN AGAIN BECAUSE HER SPASTICITY WAS BAD AGAIN. IN (B)(6) 2010, THE PT FELL FROM A MAJOR SPASM AND BROKE HER HIP/FEMUR; IT REQUIRED EMERGENCY SURGERY. WHEN THE PT WAS HOSPITALIZED FOR THE BROKEN HIP IT WAS DETERMINED THAT THE PUMP WAS SPINNING AGAIN (IT HAD COME LOOSE AGAIN) AND SHE REQUIRED A FOURTH SURGERY ON (B)(6) 2010 TO REATTACH THE PUMP AGAIN. FOLLOWING SURGERY, THE PT BELIEVED THAT THE PUMP NEVER WORKED RIGHT. WHEN SHE WAS SENT HOME, SHE BEGAN SHOWING SIGNS OF WITHDRAWAL. WHEN SHE CALLED THE SURGEONS EMERGENCY NUMBER SHE WAS TOLD THAT THE PUMP HAD NOT BEEN PRIMED AFTER THE SURGERY AND SHE SHOULD HAVE BEEN INSTRUCTED TO TAKE ORAL BACLOFEN. THE PT WAS IN THE PROCESS OF "SHUTTING THE PUMP DOWN" AND WAS CONSIDERING HAVING IT REMOVED. THE PT FELT THIS WAS UNFORTUNATE BECAUSE THE PUMP WAS A "WONDERFUL, LIFE CHANGING, EXPERIENCE WHEN IT WORKED". ADDITIONAL INFO HAS BEEN REQUESTED A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N223467006| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N223070| IMPLANTED:| EXPLANTED: