BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2210282 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06168
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 18, 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
    UT, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2011, THE PATIENT WAS PUT IN AN INDUCED COMA FOR 10-12 DAYS FOLLOWING SEIZURES AND A STROKE. DURING THIS PERIOD, THE PATIENT LOST WEIGHT AND WENT FROM A SIZE 36 TO 32 INCH WAIST AND WENT FROM 250 TO 175 POUNDS. THE PATIENT'S PUMP "NOW PROTRUDED FROM HIS ABDOMEN", GETTING CAUGHT ON THINGS AND "HURTS WHEN HE PUSHES ON IT."

    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 54 YR Male Other CATHETER: MODEL 8709, LOT # J11308R58.| EXPLANTED:| IMPLANTED: | CATHETER: MODEL 8709, LOT # J11308R58| IMPLANTED:| EXPLANTED: