BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953392 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01079
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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).

    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 PATIENT PRESENTED WITH SYNCOPE SECONDARY TO THE PACING AT VVI 65 DUE TO THE DEVICE BEING AT ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THE PATIENT WAS VERY ACTIVE. IT WAS FURTHER REPORTED THAT BOTH THE ATRIAL AND VENTRICULAR LEADS TRIGGERED A LEAD WARNING FOR LOW IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEADS WERE CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57014 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)