BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 2953444 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01113
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS 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 AT IMPLANT THE ATRIAL TINED LEAD HAD MARGINAL THRESHOLDS AFTER A DIFFICULT CASE. TWO DAYS LATER THE THRESHOLDS HAD NOT IMPROVED DUE TO POOR LEAD POSITION SO THE LEAD WAS EXPLANTED AND AN ACTIVE FIXATION LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56040 TBD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR