BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2210281 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06173
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    May 13, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LOSS OF THERAPEUTIC RELIEF, ESPECIALLY INCREASED PAIN WAS REPORTED DUE TO KINK IN CATHETER. DRUGS INFUSED INCLUDED MORPHINE, BUPIVACAINE AND CLONIDINE. ON (B)(6) 2011, THE CATHETER ACCESS PORT (CAP) CONTRAST STUDY REPORTED AS UNABLE TO ASPIRATE FLUID. A CATHETER SURGICAL REPOSITIONING WAS DONE ON THE SAME DAY. THE OUTCOME WAS REPORTED AS AN ONGOING EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention CATHETER: MODEL 8709, LOT # N195545018| IMPLANTED:| EXPLANTED: