BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2000327 · Received February 18, 2011

    Report

    Report Number
    3004209178-2011-01222
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. PATIENT HAD A REVISION IN THE PAST, BUT WAS TOLD BY THE PHYSICIAN HE HAD TOO MUCH SCAR TISSUE. PATIENT ONLY FEELS STIMULATION ON THE RIGHT SIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD049203N| IMPLANTED:| LEAD: MODEL 3777, LOT# V048439012| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V047815014| ACCESSORY: MODEL 37752, LOT# NKA031223N