BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953607 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01318
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 12, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD NO CAPTURE AT 10V. THEREFORE THE LV LEAD WAS CAPPED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56172 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R 7304 IMPLANTABLE PACEMAKER CARDIO/DEFIB