BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 3153584 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06091
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. CONCOMITANT PRODUCT: 5024M58, IMPLANTABLE PACING LEAD, (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FAILURE TO CAPTURE ON THE ATRIAL LEAD. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS ENROLLED IN THE (B)(4). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257056 TBD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5524M-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R SEDR01 IMPLANTABLE PULSE GENERATOR