BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1905454 · Received November 23, 2010

    Report

    Report Number
    2649622-2010-12128
    Event Type
    Death
    Date Received
    November 23, 2010
    Date of Event
    August 8, 2009
    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
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) BATTERY DEPLETION-NORMAL. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LIFE PARTNER THAT SHE QUESTIONED IF THE DEVICE PROVIDED THERAPY AT THE TIME OF THE PATIENT'S DEATH AND THAT THE "LEAD WIRE FRIED." THE PATIENT HAD RECENTLY COMPLETED TESTING FOR HEART TRANSPLANT AND "ALL GOOD." THE PATIENT HAD COMPLAINED OF "BUZZING IN MY CHEST" (NOT PAIN) THE NIGHT BEFORE HE DIED AND "CAN'T BREATHE" IN THE EARLY AM. 911 WAS CALLED AND THE MEDICS ARRIVED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENTS LIFE PARTNER THAT SHE QUESTIONED IF THE DEVICE PROVIDED THERAPY AT THE TIME OF THE PATIENT DEATH AND THAT THE "LEAD WIRE FRIED." THE PATIENT HAD RECENTLY COMPLETED TESTING FOR HEART TRANSPLANT AND "ALL GOOD." THE PATIENT HAD COMPLAINED OF "BUZZING IN MY CHEST" BUT NOT PAIN THE NIGHT BEFORE HE DIED AND "CAN'T BREATH" IN THE EARLY AM. 911 WAS CALLED AND THE MEDICS ARRIVED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC REVEALED THERE WAS NO "FRIED LEAD." DEVICE INTERROGATION AFTER DEATH SHOWED DEVICE FUNCTIONING FINE, DELIVERED SHOCKS, BUT PATIENT'S HEART DID NOT RESPOND. CLINIC HAS "NO CONCERNS ABOUT THE PATIENT'S DEVICE SYSTEM PERFORMANCE PRIOR TO OR AT THE TIME OF DEATH." PATIENT HAD NOT BEEN PACEMAKER DEPENDENT. LAST DEVICE CHECK WAS ONE MONTH PRIOR TO DEATH AND THERE WERE NO RHYTHM ISSUES AND DEVICE WAS FUNCTIONING FINE WITHIN NORMAL PARAMETERS.

    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 65 YR Death| H| L| R