BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113771 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03926
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DAY AFTER A ROUTINE PUMP REPLACEMENT, THE PT EXPERIENCED TACHYCARDIA, INCREASED SPASTICITY, HYPERTENSION, INSOMNIA, MILD/LOCALIZED URTICARIA, ABDOMINAL TENDERNESS, AND RESPIRATORY FAILURE. THE PT WAS INTUBATED AND HOSPITALIZED. ON (B)(6) 2011, AN X-RAY/CT SCAN SHOWED AN ABDOMINAL FLUID COLLECTION. IT WAS DETERMINED THAT THERE WAS A BREAK/TEAR/HOLE AT THE PUMP/CATHETER CONNECTION SITE. THE LEAK IN THE CATHETER WAS CAUSING ACUTE WITHDRAWAL. THE CATHETER WAS REVISED. THE PT OUTCOME WAS REPORTED AS "SERIOUS LIFE THREATENING INJURY/ILLNESS-RECOVERED WITH SEQUELA". IT WAS NOTED THAT THE PT DEVELOPED A PRESSURE ULCER. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL 2000 MCG/ML AT 350 MCG/DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J52909R33| IMPLANTED:| LOT# NGV003761N| IMPLANTABLE INFUSION PUMP: MODEL 863740| IMPLANTED: