BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2161978 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05277
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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 HAD HIGH IMPEDANCES ON ONE OF THEIR LEADS. THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD WAS RETURNED TO THE MFR BUT IT WAS UNCLEAR WHICH OF THE 2 LEADS WAS INVOLVED AS THEY HAD THE SAME MODEL NUMBER. ADDITIONAL INFO WAS REQUESTED TO CLARIFY THE LEAD IDENTITY AND THE PT OUTCOME.

    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 48 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777-60, LOT# V022590007| LEAD: MODEL 3777-60, LOT# V022590008| PROGRAMMER: MODEL 37742, LOT# NJD041827N| ACCESSORY: MODEL 37752, LOT# NKA025250N