BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4100916 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17331
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, LOT# N181539012, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A CATHETER REVISION ABOUT ONE YEAR PRIOR TO (B)(6) 2014. IT WAS NOT REPORTED WHAT THE DRUG CONTAINED AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE REASON FOR THE REVISION, PATIENT SYMPTOMS, PATIENT OUTCOME, AND THE DRUG INFUSED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY FOR 2 WEEKS PRIOR TO THE REVISION. UPON SURGICAL INTERVENTION ON (B)(6) 2012, A CATHETER ISSUE WAS IDENTIFIED. INTRAOPERATIVELY, NO CEREBROSPINAL FLUID (CSF) COULD BE ASPIRATED FROM THE SIDE PORT. THE PUMP SEGMENT WAS REMOVED AND PULLED BACK FROM THE ABDOMEN THROUGH THE LUMBAR INCISION. A KINK WAS NOTED JUST BEYOND THE ANCHOR IN THE LUMBAR REGION. WHEN THE CATHETER WAS CUT AND THE KINKED AREA WAS REMOVED, THE INTRATHECAL PIECE FLOWED WITH CSF. THE INTRATHECAL PIECE WAS KEPT IN PLACE AND RECONNECTED TO A NEW PUMP SEGMENT. FOLLOWING THE REVISION, THE PATIENT RECEIVED EFFECTIVE THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECEIVING ORAL MEDICATIONS. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584906 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention