BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3233609 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11953
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    April 2, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PUMP WAS REMOVED PER THE PATIENT¿S REQUEST BECAUSE THE PATIENT FELT THAT THE PUMP WASN'T CONTROLLING HIS SYMPTOMS. REPROGRAMMING WAS OFFERED BY THE PHYSICIAN BUT THE PATIENT REFUSED AND WANTED THE PUMP EXPLANTED. NO TROUBLESHOOTING WAS PERFORMED ON THE PUMP SINCE THE ARVS (ACTUAL RESERVOIR VOLUMES) AND EVRS (EXPECTED RESERVOIR VOLUMES) MATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING BENEFIT AFTER IMPLANT; HE HAD AN INCREASE IN DISABILITY AND A REDUCTION OF MOBILITY. THE PATIENT WAS IMPLANTED TO DECREASE SPASMS AND INCREASE MOBILITY. FOLLOWING IMPLANT, HE COULD NO LONGER WALK (HE HAD A LOSS OF LOWER EXTREMITY RANGE OF MOTION) AND INCREASED SPASTICITY IN HIS LOWER EXTREMITIES. THE MEDICATION DIDN¿T HELP WITH HIS SPASTICITY. THE PUMP WAS EXPLANTED. THE CATHETER WAS LEFT IN PLACE AND TIED OFF. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE - NO INJURY/NO ADVERSE EVENT.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE SYSTEM WAS USED TO INFUSE UNKNOWN BACLOFEN. THE CAUSE OF THE EVENT WAS NOTED AT ¿PATIENT REFUSAL.¿ THE PUMP WAS EXPLANTED, IT WAS UNKNOWN IF IT WAS TO BE RETURNED TO THE MANUFACTURER. THE PATIENT REQUIRED HOSPITALIZATION AS A RESULT OF THE EVENT AND THE OUTCOME WAS NOTED AS SERIOUS INJURY/ILLNESS- ONGOING. IT WAS ALSO NOTED THAT THE ¿PATIENT STATED HE COULDN¿T AMBULATE AFTER SURGERY IMPLANT PUMP.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PUMP WAS DELIVERING BACLOFEN. PER THE HEALTHCARE PROVIDER, THE CAUSE OF THE EVENT WAS NOTED TO BE ¿PATIENT REFUSAL¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333136 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R