BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2171027 · Received June 30, 2011

    Report

    Report Number
    3004209178-2011-04975
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE. A REVISION WAS PLANNED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORY: MODEL 37752, LOT# NKA148190N| EXPLANTED:| LEAD: MODEL 3778, LOT# V423044031| PROGRAMER: MODEL 37743, LOT# NKE133590N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTERNAL DEVICE: MODEL 37751, LOT# UNKNOWN| LEAD: MODEL 3778, LOT# V481240017