BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2884040 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12181
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODCATHETER: MODEL 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A WITHDRAWAL WAS REPORTED. IT WAS NOTED THAT THE PATIENT HAD A FALL, THE DAY AFTER THE FALL HE WAS SUPPOSED TO, BUT DID NOT END UP HAVING, A REFILL. THREE DAYS AFTER THE FALL, HE WAS ADMITTED TO THE HOSPITAL FOR AN UNRELATED BLADDER INFECTION. THE PATIENT REPORTED 'THE CATHETER LOOKED LIKE IT MOVED IN MY BACK,' BUT ALSO NOTED THAT NO DYE STUDY HAD BEEN DONE AS OF THE TIME OF THIS REPORT. IT WAS ALSO NOTED THAT THE PUMP STARTED ALARMING THE DAY AFTER HOSPITAL ADMISSION, NO TELEMETRY WAS PERFORMED AS OF THE TIME OF THIS REPORT. THE PATIENT EXPERIENCED A 'REALLY BAD HEADACHE,' ABDOMINAL PAIN, ITCHING, DIZZINESS AND SHAKING LEGS 'MORE THAN USUAL.' THE DEVICE SYSTEM WAS USED TO INFUSE BACLOFEN. 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 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization