BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1911848 · Received December 1, 2010

    Report

    Report Number
    2649622-2010-12177
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    October 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE INITIAL REPORTED EVENT WAS RECEIVED ON 10/30/2010. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 12/10/2010. INFORMATION WAS SUBSEQUENTLY RECEIVED ON 11/24/2010 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) CONNECTOR OTHER, DEFIB CONDUCTOR FRACTURE (OVERSTRESS), OUTER INSULATION COSMETIC ESC AND DEPRESSION. ANALYST VISUAL COMMENT - THE LEAD WAS RETURNED WIT THE SVC AND THE RC DEFIB CABLES FRACTURED AT THE CONNECTOR. ALSO, INTERMITTENCY BETWEEN THE CONNECTOR PIN AND CAP. 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. FOLLOW UP LATER REVEALED THE PATIENT HAD DIED IN HOSPICE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP LATER REVEALED THE PATIENT HAD DIED IN (B)(6). THE DEATH CERTIFICATE NOTED THE CAUSE OF DEATH TO BE CONGESTIVE HEART FAILURE. THERE HAD BEEN NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES OR CONCERNS. THE DEVICE HAD BEEN TURNED OFF 12 DAYS PRIOR TO DEATH. NO AUTOPSY WAS PERFORMED. UNKNOWN TO THE CLINIC IF THE PATIENT HAD BEEN PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD