BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152014 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05566
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THERE WAS SEVERE EXPLANT DAMAGED ON DISTAL SEGMENT (OUTER INSULATION BREACHED/EXTRINSIC/PULLED/STRETCHED/OVERSTRESS, AND BOTH COILS STRETCHED TO 25CM). CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 694965, TACHY LEAD: IMPLANTED: (B)(6) 2006. PRODUCT ID D154ATG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD):  IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD CAME OUT DURING EXTRACTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE RA LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252752 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R