BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2231953 · Received September 1, 2011

    Report

    Report Number
    2649622-2011-13765
    Event Type
    Death
    Date Received
    September 1, 2011
    Date of Event
    May 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ALL INFORMATION THAT HAS BEEN MADE AVAILABLE TO MEDTRONIC HAS BEEN REPORTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE FORWARDED.

    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. ALL INFORMATION THAT HAS BEEN MADE AVAILABLE TO MEDTRONIC HAS BEEN REPORTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE FORWARDED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. ALL INFORMATION THAT HAS BEEN MADE AVAILABLE TO MEDTRONIC HAS BEEN REPORTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE FORWARDED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO AN EMERGENCY ROOM IN CARDIAC ARREST AND EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE. NO COMPLAINTS OR ALLEGATIONS AGAINST THE DEVICE HAVE BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

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