BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2251582 · Received September 14, 2011

    Report

    Report Number
    3004209178-2011-07838
    Event Type
    Injury
    Date Received
    September 14, 2011
    Report Date
    September 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT EXPERIENCED INCREASED SPASTICITY, MENTAL STATUS CHANGES, DIAPHORESIS, AND DIFFICULTY URINATING. NO FEVER OR URINARY TRACT INFECTION WAS REPORTED. THE PT WAS SEEN IN A CLINIC FOR A ROUTINE PUMP REFILL. IN REGARDS TO THE PT'S PUMP, A VOLUME DISCREPANCY WAS NOTED. THE ACTUAL RESIDUAL VOLUME (6.0 ML) WAS FOUND TO BE GREATER THAN EXPECTED RESIDUAL VOLUME (3.6 ML). A (B)(6) STUDY PERFORMED ON (B)(6) 2011, CONFIRMED A MOTOR STALL HAD OCCURRED. A PRIMING BOLUS OF 0.01 OVER 1 MINUTE WAS PROGRAMMED; AND BEFORE AND AFTER PICTURES CONFIRMED NO ROLLER MOVEMENT. A CATHETER DYE STUDY REVEALED A PATENT CATHETER. PUMP REPLACEMENT OPTIONS WERE BEING DISCUSSED. IT WAS LATER REPORTED THAT SURGERY WAS SCHEDULED FOR LATER IN (B)(6) 2011. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention CATHETER: MODEL 8709SC, LOT# N202969009| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N202969009| IMPLANTED:| EXPLANTED: