BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1935924 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10191
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED COUPLING AND OR COMMUNICATION ISSUES. AN X-RAY CONFIRMED THAT THE NEUROSTIMULATOR (INS) WAS FLIPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR IMPLANTED:| LEAD: MODEL 3777, LOT# V482123034| IMPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 246040001| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V482123033| ACCESSORY: MODEL 37752, LOT# NKA135926N| PROGRAMMER: MODEL 37743, LOT# NKE150742N