BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2143004 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04688
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 26, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT EXPERIENCED NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT ASSOCIATED WITH THE LOSS OF STIMULATION. THE PT MET WITH THE COMPANY REP WHO NOTED THAT THE NEUROSTIMULATOR WAS ON AND THAT NO CYCLING HAD BEEN PROGRAMMED FOR THE PT. THE PT HAD SORENESS AT THE POCKET SITE. IMPEDANCE MEASUREMENTS WERE NORMAL. SUBSEQUENT INFO RECEIVED INDICATED THAT THE PT HAD A REVISION PERFORMED ON (B)(6) 2011. ALL COMPONENTS EXCEPT FOR THE NEUROSTIMULATOR WERE REPLACED AND BOTH INTRA-OPERATIVE AND POST OPERATIVE IMPEDANCE MEASUREMENTS WERE REPORTED AS GOOD. AT F/U, THE PT'S PAIN SCORE WENT FROM 6 TO 3 WITH 80% RELIEF NOTED. THE PT WAS REPORTED AS HAPPY WITH THE THERAPY.

    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 49 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE125927N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU101531V| PROGRAMMER: MODEL 7435, LOT# NFT054321P| EXTENSION: MODEL 7489, LOT# NHU101532V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# J0540957V| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA131036N| ADAPTER: MODEL 74002, LOT# N212500| IMPLANTED:| LEAD: MODEL 3887, LOT# J0540957V| EXPLANTED: