BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1832263 · Received September 3, 2010

    Report

    Report Number
    3004209178-2010-06767
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 9, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE PT FELT A SURGING SENSATION. PTS FELT A "STINGING SENSATION" IN HER FACE. THIS HAPPENED AFTER SOME TYPE OF ENVIRONMENTAL EXPOSURE. THIS HAS HAPPENED TWO TIMES, BOTH WHILE AT WORK. THE LOCATION OF SYMPTOMS IS AT THE LEAD LOCATION, ON THE FACE. THE PT REPORTED A STATUS OF GOOD. ADD'L INFO HAS BEEN REQUESTED, BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR LEAD, MODEL: 3888, LOT# V472483| ACCESSORY, MODEL: 37752, LOT# NKA141444N| EXTENSION, MODEL: 37083, LOT# NKC002940V| EXTENSION, MODEL: 37083, LOT# NKC002941V| PROGRAMMER, MODEL: 37743, LOT# NKE149086N