BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952284 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00474
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    February 16, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. CONCOMITANT PRODUCT: 4076, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. IT WAS NOTED THAT THE OUTER INSULATION OF THE LEAD WAS CUT AND BLOOD WAS FOUND ON THE DISTORTED PROXIMAL END. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH TISSUE/FIBROTIC GROWTH ON THE HELIX, AND A SMALL AMOUNT OF APPARENT EXPLANT DAMAGE. HELIX WAS CLEANED AND HELIX EXTENSION/RETRACTION/LENGTH TESTING WAS PERFORMED. ALL RESULTS, INCLUDING ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. THERE WAS NO CLEAR SIGN OF TWIDDLING OF LEAD AND NO EXTENSIVE DAMAGE TO LEAD AS IT WAS RETURNED. LEAD WAS THOROUGHLY ANALYZED IN AN ATTEMPT TO FIND THE FRACTURE MENTIONED IN THE EVENT. A FRACTURE WAS NOT OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWIDDLED THE ATRIAL LEAD INTO THE POCKET, RESULTING IN POCKET STIMULATION DURING PACING AND NO ATRIAL CAPTURE. IT WAS FURTHER REPORTED THE LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57073 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R ADDRL1 IMPLANTABLE PULSE GENERATOR