BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2864989 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17642
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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).ADD'L DEVICES: 5076 IMPLANTABLE PACING LEAD (B)(6) 2006; IMPLANTABLE TACHY LEAD (B)(6) 2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS AND CAUSED POCKET STIMULATION. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)