BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1072133 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03860
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    January 18, 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 RETURNED AND ANALYZED. IT WAS REPORTED THE LEAD WAS REPLACED DUE TO HIGH THRESHOLDS AND UNDERSENSING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED, ACCORDING TO SPECIFICATIONS DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED UNDERSENSING HIGH THRESHOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REPLACED DUE TO HIGH THRESHOLDS AND UNDERSENSING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEDR01 IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD