BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1942625 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10005
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    August 14, 2008
    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 MANUFACTURE EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED DRAINAGE IN THE RIGHT FLANK OVER THE INCISION MADE FOR THE CONNECTOR FOR THE BIFURCATED EXTENSION. THE PATIENT WAS DIAGNOSED WITH AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. THE SYSTEM WAS EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention PROGRAMMER: MODEL 37742, LOT #: NJD024203N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT #: V096185| IMPLANTED:| EXTENSION: MODEL 37082, LOT #: NKB000984N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT #: V098886| IMPLANTED:| LEAD: MODEL 3487A, LOT #: V096185| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT #: NKB000985N| IMPLANTED:| LEAD: MODEL 3487A, LOT #: V098886