BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202732 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04896
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    May 23, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP MOVED DUE TO PATIENT LOST WEIGHT. THE PATIENT WAS EXTREMELY ¿HUNCHED FORWARD¿ AND HAD ¿QUITE A BIT OF DEFORMITY.¿ IT WAS NOTED THAT THE PATIENT HAD A SPINE THAT WAS ¿BASICALLY FALLING APART.¿ THE PUMP WAS PLACED ¿FAIRLY CLOSE TO THE MID-LINE¿ BECAUSE, THE PATIENT WAS IN A WHEELCHAIR AND IT WAS VERY ¿DIFFICULT AND UNCOMFORTABLE¿ TO TRANSFER THE PATIENT FROM THE WHEELCHAIR FOR REFILLS. THE PATIENT COULD HARDLY LIE DOWN. SHE WAS ¿DEBILITATED.¿ THE PATIENT WAS HAVING TROUBLE WITH NUTRITION AND HAD LOST WEIGHT. HER BODY SHAPE HAD CHANGED AND SHE WAS ¿HUNCHED OVER¿. THE PUMP HAD MOVED CLOSER TO THE UMBILICUS. THE HEALTH CARE PROFESSIONAL DID NOT PLAN A PUMP REVISION BECAUSE THEY FELT THAT IT WOULD BE GREATER RISK FOR THE PATIENT TO DO A PUMP REVISION. THE PUMP WAS BEING USED TO DELIVER HYDROMORPHONE AND ROPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300924 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1