BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2813144 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17218
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND DURING ANALYSIS. THERE WAS APPARENT EXPLANT DAMAGE. BLOOD WAS NOTED ON THE DISTAL AND PROXIMAL CONDUCTORS AND THE DISTAL ELECTRODE. THE PROXIMAL CONDUCTOR WAS KINKED/BUCKLED. A WHITE SUBSTANCE WAS NOTED ON THE OUTER INSULATION. COSMETIC ENVIRONMENTAL STRESS CRACKING, COSMETIC DEPRESSION AND A BREACH CUT WERE NOTED ON THE OUTER INSULATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH THRESHOLD AND THE PATIENT WAS ADMITTED FOR LEAD EXTRACTION WHEN THE GENERATOR WENT TO ELECTIVE REPLACEMENT INDICATOR. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 4092 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR