BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1972415 · Received January 24, 2011

    Report

    Report Number
    3004209178-2011-00570
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT UNDERWENT A CANCER REMOVAL PROCEDURE WHICH USED LIQUID NITROGEN AND SUBSEQUENTLY LOST STIMULATION. HE WAS PROGRESSIVELY SHAKIER OVER A TWO DAY PERIOD AND THEN HE LOST STIMULATION. IT WAS FURTHER STATED THAT THE PT UNDERWENT A SURGICAL PROCEDURE IN WHICH ELECTROCAUTERY WAS USED AND THAT AFTERWARD THE DEVICE WAS DEAD. IT WAS NOT CLEAR IF THIS PROCEDURE WAS IN ADDITION TO THE CANCER REMOVAL PROCEDURE. THE STIMULATOR WAS REPLACED AND FOLLOWING REPLACEMENT, EVERYTHING WAS FINE. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention LEAD: MODEL 3382, LOT#: L33167| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-1, LOT# XR0023345N| IMPLANTED: