BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2810613 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15772
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. IMPEDANCE/HIGH IMPEDANCE: V-LEAD IMPEDANCE TREND BEGINS A LINEAR RISE OVER 17 WEEKS BEFORE LEAD WAS REVISED. THRESHOLDS: THRESHOLDS INCREASE OVER 16 WEEKS, STARTING 27-MAY, TOPPING OUT AT 1V. WITHIN NORMAL RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED SLOWLY INCREASING THRESHOLDS AND IMPEDANCES, REACHING HIGH LEVELS OF IMPEDANCE. IT WAS FURTHER REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED SLOWLY INCREASING THRESHOLDS AND IMPEDANCES, REACHING HIGH LEVELS OF IMPEDANCE. IT WAS FURTHER REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB