BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3062209 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05090
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. DEVICE: 6725 ADAPTOR (B)(6) 2012; 6935 IMPLANTABLE TACHY LEAD (B)(6) 2001; D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD THRESHOLD HAD INCREASED OVER SEVERAL MONTHS. DURING THE LEAD REVISION PROCEDURE, THE LEAD "SEEMED FINE." THE LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163952 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD