BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2032886 · Received March 29, 2011

    Report

    Report Number
    2649622-2011-04248
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    January 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0067-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGAMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THE OUTER INSULATION HAD COSMETIC DEPRESSION AND VISUAL ANALYSIS WAS PERFORMED ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FAINTED AT HOME AND WAS FOUND IN ASYSTOLE. RESUSCITATION EFFORTS WERE DONE INCLUDING EXTERNAL DEFIBRILLATION DUE TO PATIENT BEING IN VENTRICULAR TACHYCARDIA. THE PATIENT RETURNED TO NORMAL SINUS RHYTHM, BUT WAS IN A COMA. THE PATIENT SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS REQUESTED BUT NOT RECEIVED. NO FURTHER INFORMATION WILL BE AVAILABLE. IT WAS ALSO REPORTED A DEVICE MANUAL DUMP TEST WAS PERFORMED WHILE THE PATIENT WAS IN A COMA IN THE INTENSIVE CARE UNIT. THE PATIENT HAD A VENTRICULAR TACHYCARDIA EPISODE WITH RR INTERVALS OF 500MS. EPISODES ON THE DEVICE DID NOT REGISTER ANY VENTRICULAR TACHYCARDIA EPISODES LASTING LONGER THEN TWO SECONDS. THE PATIENT DIED FIVE DAYS AFTER BEING IN A COMA IN THE INTENSIVE CARE UNIT. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE AND/OR LEAD RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6930 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H| L| R