BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1870754 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07866
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD DIFFICULTIES RECHARGING THE DEVICE. THE REPORTER BELIEVED THE DEVICE WAS FAULTY, AND THE DEVICE WAS REPLACED. AFTER THE DEVICE WAS EXPLANTED, THE RECHARGER WAS PUT ON THE DEVICE AND EVERYTHING WAS NORMAL. THE PT RECOVERED WITHOUT SEQUELA.

    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 69 YR Required Intervention LEAD: MODEL 39565-65, LOT# V387293009| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE141503N| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA136430N