BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1942623 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10006
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    July 22, 2005
    Report Date
    September 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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

    THE PATIENT HAD PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE; TENDERNESS UNDER THE RIGHT ANTERIOR COSTAL MARGIN. THE INS WAS SURGICALLY REVISED ON (B)(6) 2005. THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 49 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT #: N27084| EXTENSION: MODEL 7489, LOT #: NHU084845V| LEAD: MODEL 3986A, LOT #: N27084| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT #: NHU084843V| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT #: NFT050584P