BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3221184 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11622
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 19, 2013
    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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CATHETER REPLACEMENT, THOUGH WHAT NECESSITATED THE REPLACEMENT WAS NOT STATED. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE EVENT WAS CAUSED BY THE PUMP BATTERY BEING CHANGED, BUT A SECOND PROCEDURE WAS NEEDED FOR THE CATHETER. IT WAS INDICATED THAT PATIENT HAD EXHIBITED A LACK OF BENEFIT. A CATHETER DYE STUDY HAD BEEN PERFORMED AND IT WAS SEEN THAT THERE WAS A KINK AT THE PUMP AND CATHETER CONNECTION. THAT SAME DAY, SURGICAL INTERVENTION OCCURRED TO REPLACE THE CATHETER. NO HOSPITALIZATION WAS REQUIRED DUE TO THIS EVENT, BUT THERE HAD BEEN A ¿NON-SERIOUS INJURY/ILLNESS¿. IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA AND HAD BEEN DOING WELL SINCE THE CATHETER WAS REPLACED. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320115 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention