BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 3062180 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05121
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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). DEVICE: 5024M IMPLANTABLE PACING LEAD (B)(6) 1994.

    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 ATRIAL LEAD HAD ELEVATED THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163875 TBD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5524M-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 294-05 COMPETITOR IMPLANTABLE PULSE GENERATOR (IPG