BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2042679 · Received April 6, 2011

    Report

    Report Number
    2649622-2011-04412
    Event Type
    Death
    Date Received
    April 6, 2011
    Date of Event
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON LEAD RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A LEAD-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2011. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. EVALUATION SUMMARY: (B)(4) ANALYSIS FOUND AN OUTER INSULATION BREACHED DEPRESSION. THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS ALSO PRESENT IN/ON ALL CONDUCTORS, AND THERE WAS AN OUTER INSULATION COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    THE ATRIAL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR