BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1722959 · Received June 15, 2010

    Report

    Report Number
    2649622-2010-06829
    Event Type
    Death
    Date Received
    June 15, 2010
    Date of Event
    May 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY (B) (4) PIN/PLUG CRIMP DEFECTIVE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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. IT WAS REPORTED THE PATIENT ARRESTED AT HOME AND "THIS PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE AND MAY HAVE HAD THAT DEVICE FAIL."

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. IT HAS BEEN REPORTED THE PATIENT ARRESTED AT HOME AND "THIS PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE AND MAY HAVE HAD THAT DEVICE FAIL." FOLLOW UP WITH THE HCP REPORTED THE CAUSE OF DEATH WAS "MALFUNCTION OF HMZ LVAD - SUDDEN DEATH" AND NOT RELATED TO THE GENERATOR OR LEAD.

    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 61 YR Death D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5071 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD