BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2864848 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17671
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND THERE WAS A BREACH IN THE OUTER INSULATION DUE TO RIB/CLAVICLE. IT WAS ALSO NOTED THAT THE DISTAL ELECTRODE WAS COVERED IN BLOOD AND BODY TISSUE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THE CONDUCTOR HAD BLOOD (NOT OBSTRUCTED). ADD'L DEVICE: SEDR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. AN ATTEMPT WAS MADE TO PUT IN A NEW RV LEAD ON THE LEFT SIDE BUT WAS TOO TIGHT AND THE LEAD WOULD NOT ADVANCE. THE RV NEW LEAD WAS PLACED ON THE RIGHT SIDE. NO 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 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD