BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1071724 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03880
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    June 9, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IMPEDANCES READINGS >3600 OHMS. THE PATIENT EXPERIENCED SHOCKING IN THEIR ARMS AND A LOSS THERAPEUTIC EFFECT. THE HCP NOTED, THE PATIENT HAD A BROKEN CONNECTOR AND EVENTUALLY WILL HAVE A LEAD REVISION. NO OUTCOME WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD MODEL 3487A LOT# L73475| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 37083 LOT# NKC003476N| EXPLANTED: