BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2566908 · Received May 9, 2012

    Report

    Report Number
    2649622-2012-05338
    Event Type
    Death
    Date Received
    May 9, 2012
    Date of Event
    April 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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). THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS VENTRICULAR NON-SUSTAINED TACHYCARDIA (NST)<=216 MILLISECONDS (MS) ON (B)(4) 2012. VENTRICULAR FIBRILLATION (VF)<=210 MS AVERAGE VENTRICULAR-CYCLE OCCURRED ON (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM IN CARDIAC ARREST. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT PROVIDING DEFIBRILLATION THERAPY, WAS NOT ALWAYS SENSING AND WAS NOT CAPTURING. ADDITIONAL INFORMATION OBTAINED INDICATED THE PATIENT HAD BEEN SEEN IN THE EMERGENCY ROOM EARLIER IN THE DAY FOR SYNCOPE, LIGHTHEADEDNESS AND WAS EVALUATED AND DISCHARGED TO HOME WITH A DIAGNOSIS OF SYNCOPE, VASOVAGAL EPISODE, CARDIAC DYSRHYTHMIA, HYPOKALEMIA AND RENAL DYSFUNCTION. THE PATIENT'S FAMILY WAS LATER UNABLE TO REACH THE PATIENT AND EMERGENCY MEDICAL SERVICES FOUND THE PATIENT PULSELESS AND UNRESPONSIVE. THE PATIENT WAS RETURNED TO THE EMERGENCY ROOM, WAS INTUBATED AND EXTERNALLY PACED. INTERROGATION OF THE DEVICE NOTED NO CAPTURE, NO VISIBLE OR MEASURABLE R WAVES AND TWELVE EPISODES OF VENTRICULAR FIBRILLATION HAD BEEN RECORDED. AN ELECTROENCEPHALOGRAM WAS PERFORMED AND INDICATED NO BRAIN ACTIVITY AND THE PATIENT DIED THE SAME DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM IN CARDIAC ARREST. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT PROVIDING DEFIBRILLATION THERAPY, WAS NOT ALWAYS SENSING AND WAS NOT CAPTURING. ADDITIONAL INFORMATION OBTAINED INDICATED THE PATIENT HAD BEEN SEEN IN THE EMERGENCY ROOM EARLIER IN THE DAY FOR SYNCOPE, LIGHTHEADEDNESS AND WAS EVALUATED AND DISCHARGED TO HOME WITH A DIAGNOSIS OF SYNCOPE, VASOVAGAL EPISODE, CARDIAC DYSRHYTHMIA, HYPOKALEMIA AND RENAL DYSFUNCTION. THE PATIENT'S FAMILY WAS LATER UNABLE TO REACH THE PATIENT AND EMERGENCY MEDICAL SERVICES FOUND THE PATIENT PULSELESS AND UNRESPONSIVE. THE PATIENT WAS RETURNED TO THE EMERGENCY ROOM, WAS INTUBATED AND EXTERNALLY PACED. INTERROGATION OF THE DEVICE NOTED NO CAPTURE, NO VISIBLE OR MEASURABLE R WAVES AND TWELVE EPISODES OF VENTRICULAR FIBRILLATION HAD BEEN RECORDED. AN ELECTROENCEPHALOGRAM WAS PERFORMED AND INDICATED NO BRAIN ACTIVITY AND DIED THE SAME DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L| R