BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2133554 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04455
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING SYMPTOMS OF UNDERDOSE INCLUDING SPASMS AND FEVER AFTER HAVING A ROUTINE SCHEDULED PUMP REPLACEMENT ON (B)(6) 2011, BECAUSE THE "ERI DATE REQUIRED REPLACEMENT". THERE WERE NO SYMPTOMS PRIOR TO THE REPLACEMENT. BACLOFEN WAS USED IN BOTH THE OLD AND NEW PUMP. ON (B)(6) 2011, IT WAS REPORTED THAT THE CATHETER WAS NOT TOTALLY/FIRMLY CONNECTED TO THE NEW PUMP SO PATIENT WAS NOT GETTING ANY DRUG. THE PUMP DOSE WAS INCREASED TO 850MCG WITH NO RESPONSE. A CATHETER REVISION WAS DONE (B)(6) 2011 AND THE DOSE WAS DECREASED BACK DOWN TO 650.8 MCG/DAY AT A CONCENTRATION OF 2,000 MCG/ML, THE SAME DOSE THE PATIENT HAD BEEN USING IN THE OLD PUMP. THE CATHETER WAS REPRIMED AND AN ADDITIONAL 100MCG BOLUS WAS GIVEN.

    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 32 YR Required Intervention IMPLANTABLE INFUSION PUMP: MODEL 863720| LOT# NGP003850N| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L41858| IMPLANTED:| EXPLANTED: