BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1231223 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07456
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. THIS EVENT WAS ORIGINALLY REPORTED AS A FOLLOW UP REPORT FOR MANUFACTURER REPORT # 3004209178-2008-03846.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AFTER LEAD REPLACEMENT. THE PATIENT HAD A SLIGHT TINGLING SENSATION IN THE CHEST AND UPPER SHOULDER; THE STIMULATION WAS IN THE WRONG LOCATION ON THE LEFT SIDE ONLY. THE PATIENT WAS SEEN BY A MANUFACTURER REPRESENTATIVE. IMPEDANCE READING >4000 OHMS WAS REPORTED ON ALL OR SOME OF THE BIPOLAR PAIRS. EVERYTHING WAS OVER 4000 OHMS WITH THE EXCEPTION OF 01=371 / 02, 03=415, / 12=371, 13=415 / 23=371. IT WAS SUSPECTED THERE WAS SOME TYPE OF FLUID SHORT BUT PALPATION DID NOT CAUSE ANY SYMPTOM CHANGE. AN X-RAY OF THE STIMULATOR / EXTENSION AND LEAD / EXTENSION AREAS WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR IMPLANTED:| EXLANTED:| IMPLANTED:| LEAD: MODEL UNK| EXPLANTED:| EXTENSION: MODEL 7489