BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3051794 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04909
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION SUGGESTING A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE LEAD WAS PARTIALLY RECEIVED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED AN INSULATION BREACH AND COSMETIC DAMAGE DUE TO METAL ION OXIDATION. THE OUTER INSULATION HAD ENVIRONMENTAL STRESS CRACKING AS WELL AS A BREACH CAUSED BY MELTING. THE ANALYST ALSO NOTED THAT THE DISTAL AND PROXIMAL LEAD CONDUCTORS WERE DISTORTED. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  2006-(B)(6); 6949 IMPLANTABLE TACHY LEAD 2006-(B)(6); 5076 IMPLANTABLE PACING LEAD. (B)(4).

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED AFTER BEING REMOVED; THERE WAS NO ALLEGED PERFORMANCE ISSUE ("NO COMPLAINT"). THE RV LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING 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
    152648 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR