BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1882253 · Received October 26, 2010

    Report

    Report Number
    2649622-2010-11958
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    August 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    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 DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-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 9/12/2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT SHOULD HAVE BEEN SUBMITTED ON 12/10/2010. INFORMATION WAS SUBSEQUENTLY RECEIVED ON 10/20/2010 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 (B)(4) REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. EVALUATION SUMMARY (B)(4) INNER INSULATION SEPARATION, OUTER INSULATION COSMETIC MIO AND ESC AND COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT SHOULD HAVE BEEN SUBMITTED ON (B)(6) 2010. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2010 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) OUTER INSULATION BREACHED MIO, OUTER INSULATION COSMETIC MIO AND ESC, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 5076 IMPLANTABLE PACING LEAD| E2DR01 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| E2DR01 IMPLANTABLE PULSE GENERATOR