BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD

    MDR report key: 3961791 · Received July 28, 2014

    Report

    Report Number
    2025587-2014-00526
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LDF
    PMA / PMN Number
    K012460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS EVENT OCCURRED DURING SURGERY, AND A REPLACEMENT WIRE WAS PLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE TEMPORARY PACING WIRE BEING PULLED OUT. THIS EVENT WAS ERRONEOUSLY REPORTED AS A SERIOUS INJURY. THERE WAS NO SERIOUS INJURY OR PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED OR WHEN THE INVESTIGATION IS COMPLETED. A REVIEW OF MEDTRONIC'S DATABASES DID NOT INDICATE THAT A SEPARATE REPORT EXISTS FOR THIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT TEMPORARY PACING WIRE WAS PULLED OUT OF THE HEART WHEN THE SURGEON WAS PULLING IT THROUGH THE SKIN. THERE WAS NO MALFUNCTION OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED OR WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A TEMPORARY PACING LEAD HAD DISLODGED DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439118 TEMPORARY BIPOLAR MYOCARDIAL PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY LDF MEDTRONIC HEART VALVES DIVISION 6495 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1