BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1080751 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-04263
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 26, 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

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LACK OF EFFECT, INTERMITTENT STIMULATION, AND NO STIMULATION IN A CERVICAL IMPLANT. THE IMPEDANCE READING WAS >3600 OHMS. THE LEAD WAS REPLACED. THE HEALTH CARE PROFESSIONAL WAS UNCERTAIN. IF THE ELECTRODE HAD BROKEN CONTACTS. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED,| EXPLANTED,| IMPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD53607N| IMPLANTED:| LEAD MODEL UNK SERIAL# UNK| EXTENSION MODEL 37083 LOT# NKC014067N