BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2050049 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02443
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    Adverse Event
    Yes
    Product Problem
    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

    IT WAS REPORTED THAT A POR (POWER ON RESET) CONDITION EXISTED. THIS OCCURRED FOLLOWING EMI (ELECTROMAGNETIC INTERFERENCE) EXPOSURE DURING PROCEDURE USING ELECTROCAUTERY. IT WAS NOTED THAT THE REPORTER WAS GIVEN THE DEVICE SERIAL NUMBER TO CLEAR POR AND PROGRAM DEVICE. RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR LEAD: MODEL 4351, LOT# NHT006252N| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT006251N| IMPLANTED:| EXPLANTED:| EXPLANTED: