BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2050159 · Received April 1, 2011

    Report

    Report Number
    3004209178-2011-02483
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION, AND NEVER HAD THERAPEUTIC EFFECT. THE SYMPTOMS WERE NOTED FOLLOWING A NAP THE DAY BEFORE THE REPORT. IT WAS NOTED THAT THE PATIENT COULD INCREASE THE STIMULATION, BUT COULD NOT FEEL ANYTHING. ADDITIONAL INFORMATION HAS BEEN REPORTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT # NKB002411N| EXPLANTED:| LEAD: MODEL 3888, LOT # J0357459V| LEAD: MODEL 3888, LOT # J0545162V| EXPLANTED:| IMPLANTED:| EXPLANTED: