BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1992000 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00880
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD AND STYLET HAVE BEEN RETURNED TO MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE HCP WAS UNABLE TO FULLY RE-INSERT THE STYLET INTO THE LEAD AFTER MULTIPLE TRIES. THERE WERE POSITIONING DIFFICULTIES. THE LEAD WAS REPLACED. THERE WAS NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELA AFTER REMOVAL.

    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 66 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA149095N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE162540N| EXPLANTED:| LEAD: MODEL 3778, LOT# V524347009| LEAD: MODEL 3778, LOT# V524226025| STIM ACCESSORY: MODEL STYLET/RESTORE, LOT# UNK| LEAD: MODEL 3778, LOT# V524347008