BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1213278 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06896
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    January 1, 2007
    Report Date
    September 4, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PT HAD BEEN GETTING GOOD RELIEF FROM HER SYSTEM UNTIL SHE WAS STRUCK BY A SURGE OF ENERGY IN HER YARD FROM THE POWER LINES/TRANSFORMER. THE PT STATED THAT ABOUT A YEAR AND A HALF AGO, SHE WAS SITTING IN HER YARD WHEN TREES GOT TANGLED IN THE POWER LINES ABOVE HER HOUSE AND BALL OF WHITE ENERGY BURST CAUSING CAR ALARMS TO GO OFF; THE PT REPORTED THAT SHE STOOD UP, AND THEN FELL DOWN. SHE STATED THAT HER SYSTEM HAD NOT BEEN THE SAME SINCE. THE SYSTEM WAS INTERROGATED, AND EVERYTHING LOOKED OKAY. THE PT DECIDED TO HAVE THE SYSTEM EXPLANTED.

    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 Required Intervention EXTENSION MODEL 7489| EXPLANTED:| EXPLANTED:| LEAD MODEL 3487A