BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1061589 · Received June 17, 2008

    Report

    Report Number
    2649622-2008-03253
    Event Type
    Death
    Date Received
    June 17, 2008
    Date of Event
    April 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. IT WAS REPORTED THAT OVERSENSING OF DIAPHRAGMATIC NOISE AND RV (RIGHT VENTRICULAR) PACING INHIBITION OCCURRED. THE MANUFACTURER'S PATIENT DEVICE REGISTRATION SYSTEM INDICATES THE PATIENT DIED FIVE DAYS AFTER THE REPORTED EVENT. THERE IS NO ALLEGATION THAT THE DEATH WAS DEVICE RELATED. FOLLOW-UP INFORMATION RECEIVED INDICATED THE PATIENT HAD BEEN ADMITTED WITH RESPIRATORY FAILURE, STROKE, ASPIRATION PNEUMONIA, AND CARDIOMYOPATHY. THE DEATH CERTIFICATE INDICATES THE MANNER OF DEATH TO BE NATURAL CAUSES. NO CONCLUSION CAN BE DRAWN OVERSENSING PACING INTERMITTENTLY NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING OF DIAPHRAGMATIC NOISE AND RV (RIGHT VENTRICULAR) PACING INHIBITION OCCURRED. THE MANUFACTURER'S PATIENT DEVICE REGISTRATION SYSTEM INDICATES THE PATIENT DIED FIVE DAYS AFTER THE REPORTED EVENT. THERE IS NO ALLEGATION THAT THE DEATH WAS DEVICE RELATED. FOLLOW-UP INFORMATION RECEIVED INDICATED THE PATIENT HAD BEEN ADMITTED WITH RESPIRATORY FAILURE, STROKE, ASPIRATION PNEUMONIA, AND CARDIOMYOPATHY. THE DEATH CERTIFICATE INDICATES THE MANNER OF DEATH TO BE NATURAL CAUSES.

    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 Death| O 5076 IMPLANTABLE PACING LEAD| 7289 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR