BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1070142 · Received July 3, 2008

    Report

    Report Number
    3004209178-2008-03743
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A PUMP AND CATHETER REVISION DUE TO A FLIPPED PUMP. THE PATIENT HAS NOW BEEN REFERRED FOR PUMP REPLACEMENT FOR UNSPECIFIED REASONS. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| IMPLANTED:| IMPLANTED:| EXPLANTED| CATHETER MODEL 8709 LOT# N099431018