BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1844850 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07256
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT ALONG WITH TINGLING IN HER FINGERTIPS AND OCCASIONAL WARMTH AT THE INS POCKET FOLLOWING A LIGHTENING STORM IN WHICH LIGHTENING HIT A TREE RIGHT OUTSIDE HER HOUSE. THIS OCCURRED TWO MONTHS PRIOR. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR IMPLANTED:| LEAD: MODEL 3890, LOT# J0454758V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU069583V| IMPLANTED:| LEAD: MODEL 3890, LOT# J0454663V| EXTENSION: MODEL 7489, LOT# NHU069584V| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT041778P| EXPLANTED: