BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 2964914 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01888
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 2, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4) IMPLANTABLE PULSE GENERATOR (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD DISLODGED DURING THE FIRST MONTH OF IMPLANT. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD DISLODGED DURING THE FIRST MONTH OF IMPLANT. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68559 TBD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 5092 IMPLANTABLE PACING LEAD