BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2081557 · Received April 19, 2011

    Report

    Report Number
    3004209178-2011-02919
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    A PT EXPERIENCED A DECREASE IN THERAPEUTIC BENEFIT. THE PT WAS ENROLLED INTO THE STUDY ON (B)(6) 2011; AND "KINK" WAS NOTED AS A PHYSICIAN CONFIRMED CATHETER DIAGNOSIS. THE DRUG ADMINISTERED VIA THE PUMP WAS NOTED AS "EITHER LIORESAL OR BACLOFEN (NOT COMPOUNDED)". ADD'L INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    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 56 YR CATHETER: MODEL 8709, LOT# N160028027| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8596SC, LOT# N181309025| EXPLANTED: