BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1910697 · Received November 22, 2010

    Report

    Report Number
    3004209178-2010-09866
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    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

    RECEIVED INFO REPORTING PT HAS HAVE AN INFECTION AT THE INS SITE SINCE (B)(6) 2010. AFTER REMOVING THE INCISIONAL DRESSING, THE PT NOW SEES A SMALL GRAY WHITE LOOP COMING FROM THE INCISION. ADDITIONAL INFO 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA145314N| LEAD: MODEL 3777, LOT# V550634022| PROGRAMMER: MODEL 37743, LOT# NKE155817N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V550634023