BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1072057 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03836
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: NO ANOMALIES FOUND; FULL LEAD ANALYZED IT WAS REPORTED THE PACE/SENSE LEAD WAS CAPPED DUE TO OVERSENSING. IN ADDITION, IT WAS REPORTED THE HV LEAD WAS EXPLANTED AND REPLACED DUE TO INCREASING IMPEDANCE. AT CHANGE OUT, INSULATION DEGRADATION NOTICED ON THE HV LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO CONCLUSION CAN BE DRAWN OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PACE/SENSE LEAD WAS CAPPED DUE TO OVERSENSING. IN ADDITION, IT WAS REPORTED THE HV LEAD WAS EXPLANTED AND REPLACED DUE TO INCREASING IMPEDANCE. AT CHANGE OUT, INSULATION DEGRADATION NOTICED ON THE HV LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4592 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5071 IMPLANTABLE PACING LEAD