BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2040893 · Received March 18, 2011

    Report

    Report Number
    3007566237-2011-02081
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION AFTER A CT SCAN FOR AN UNRELATED MEDICAL CONDITION. PT DID NOT TURN OFF THE DEVICE PRIOR TO THE SCAN. SINCE THE SCAN, THE PT IS NOW FEELING STIMULATION IN THE CALF, NOT THE FOOT WHERE SHE IS SUPPOSE TO FEEL STIMULATION. REPROGRAMMING HAS NOT BEEN SUCCESSFUL IN RETURNING STIMULATION TO THE FOOT. LEAD MIGRATION WAS BEING INVESTIGATED. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC NEUROMODULATION 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR LEAD: MODEL 3888, LOT# J0349335V| EXTENSION: MODEL 7489, LOT# NHU057500V| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# J0349462V| PROGRAMMER: MODEL 7435, LOT# NFT042622P| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU056907V