BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2082977 · Received May 4, 2011

    Report

    Report Number
    3004209178-2011-03229
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    January 1, 2008
    Report Date
    March 22, 2011
    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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN UNDESIRABLE CHANGE IN STIMULATION. THERE WAS NO STIMULATION AND RECURRENCE OF POST-LAMINECTOMY PAIN. THE STIMULATOR AND EXTENSION WERE REPLACED.

    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 55 YR Male Required Intervention ADAPTOR: MODEL 3550-09, LOT# L79429.| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0014200N.| EXTENSION: MODEL 7495-51, LOT# XR0078224N.| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# L20855.| LEAD: MODEL 3998, LOT# L81130.| PROGRAMMER: MODEL 7435, LOT# NFT065548P.| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# L20855| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0014200N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0078224N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# L81130| IMPLANTED:| IMPLANTED:| ADAPTOR: MODEL 3550-09, LOT# L79429| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT065548P