BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1913468 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09369
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    IT WAS REPORTED THE PT FELL (B)(6) 2010 AND WAS IN THE HOSP FOR BACK SURGERY AND REPORTED HER DEVICE HAD BEEN TURNED OFF FOR 6 DAYS; HOWEVER, SHE STILL FELT STIMULATION, AND IT WAS VERY ANNOYING. PT'S SYMPTOMS WERE AT THE INS LOCATION. PT HAD TURNED THE DEVICE DOWN TO ZERO AND SHE SAW A YELLOW LIGHT ON THE PT PROGRAMMER TO CONFIRM INS WAS OFF. THE COMPANY REP REPORTED THAT IT SEEMED THAT THE BATTERY WAS DEAD AND THEY WANTED A REPLACEMENT, BUT COULD NOT FIND A DOCTOR TO DO IT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR EXTENSION: MODEL 7496-51, LOT# YR0010235N| UNK CONVERSION TYPE: MODEL 3550-09, LOT# LB2579| PROGRAMMER: MODEL 7435, LOT# NFT049736P| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3982, LOT# NBB002663N