BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2101711 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03408
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    January 1, 2009
    Report Date
    April 24, 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
    ID, 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 A LOSS OF THERAPEUTIC EFFECT LESS THAN A MONTH AFTER IMPLANTATION. ALSO, THE PT COULD NOT GET THE NEUROSTIMULATOR TO RECHARGE. F/U INFO REC'D REPORTED THAT THE LEAD HAD MIGRATED APPROX 2 YRS AGO WHICH WAS CONFIRMED BY X-RAY AND SUBSEQUENT REPROGRAMMING. THE PT HAD LOST THEIR INSURANCE. IF ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SENT.

    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 45 YR LEAD: MODEL 3778, LOT# V143199003| IMPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA122126N| LEAD: MODEL 3778, LOT# V143199002| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE114346N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB040926V| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB030146V| EXPLANTED: