BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2120021 · Received June 8, 2011

    Report

    Report Number
    3004209178-2011-04135
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    January 26, 2017
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING BURNING IN THE POCKET SITE. IMPEDANCES WERE CHECKED WITH SEVERAL HIGH. LEAD REMOVED FROM THE INS AND CHECKED IN MLTC (MULTI LEAD TRIALING CABLE). ALL IMPEDANCES NORMAL IN MLTC. LEAD RECONNECTED TO INS. IMPEDANCES HIGH ON DIFFERENT ELECTRODES. LEADS DISCONNECTED AGAIN AND CHECKED IN MLTC WHERE ALL IMPEDANCES REMAINED NORMAL WITH MLTC BUT HIGH (AGAIN DIFFERENT ELECTRODES) WHEN CONNECTED TO INS. NEW INS OPENED AND LEADS CONNECTED WITH ALL IMPEDANCES NORMAL. THE PT WAS NO LONGER EXPERIENCING BURNING IN POCKET WITH THE NEW INS. THE PT RECOVERED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention ACCESSORY: MODEL 37752, LOT# NKA145348N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB005033V.| EXTENSION: MODEL 37082, LOT# NKB016108N.| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V210506.| LEAD: MODEL 3487A, LOT# V537001.| LEAD: MODEL 3888 LOT# V536164.| LEAD: MODEL 3888, LOT# V536164.| N/A.| PROGRAMMER: MODEL 37743, LOT# NKE156037N.| LEAD: MODEL 3487A, LOT# V210506| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE156037N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB016108N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888 LOT# V536164| LEAD: MODEL 3487A, LOT# V537001| EXTENSION: MODEL 37082, LOT# NKB005033V| LEAD: MODEL 3888, LOT# V536164| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA145348N