BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2951736 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00219
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 13, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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: (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE CONDUCTOR WAS FRACTURED PROXIMALLY AT THE FIRST RIB/CLAVICLE. THE DISTAL AND PROXIMAL CONDUCTORS WERE PULLED/STRETCHED/OVERSTRESSED; THE DISTAL AND PROXIMAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED); THE DISTAL ELECTRODE WAS COVERED IN BLOOD. THE OUTER INSULATION WAS MELTED AND TORN. THE OUTER INSULATION RIB/CLAVICLE WAS BREACHED, ALONG WITH INSULATION DEPRESSION, AND ENVIRONMENTAL STRESS CRACKING. THE INNER INSULATION HAD METAL ION OXIDATION; BREACH AND COSMETIC. CONCOMITANT PRODUCTS: 4068 IMPLANTABLE PACING LEAD (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS WERE RETURNED TO THE MANUFACTURER AFTER BEING REMOVED AND REPLACED FOR A MEDICAL JUDGEMENT UPGRADE. THE LEADS SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57284 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 8042 IMPLANTABLE PULSE GENERATOR (IPG)