BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813389 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17247
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND DURING ANALYSIS. BLOOD AND TISSUE WERE NOTED ON THE DISTAL ELECTRODE. COSMETIC ENVIRONMENTAL STRESS CRACKING AND A COSMETIC DEPRESSION WERE NOTED ON THE OUTER INSULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SIGNIFICANT WEIGHT LOSS BY THE PATIENT, THE DEVICE FELL LOWER IN THE CHEST POCKET. BOTH THE RIGHT ATRIAL AND THE RIGHT VENTRICULAR LEADS PULLED BACK OUT OF POSITION. THIS CREATED HIGH THRESHOLDS ON BOTH LEADS. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE BOTH THE LEADS AND THE DEVICE. 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 5071 IMPLANTABLE PACING LEAD