BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2813394 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03825
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K915724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF THE LEAD, A SMALL SHARD OF METAL WAS FOUND IN THE PACKAGING LYING NEXT TO THE LEAD. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE PERMANENT LEAD EXTENSION DTB MEDTRONIC, INC. 6984M

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other 1258T COMPETITOR IMPLANTABLE PACING LEAD| 4047 COMPETITOR IMPLANTABLE PACING LEAD