BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1960525 · Received January 13, 2011

    Report

    Report Number
    2649622-2011-00051
    Event Type
    Death
    Date Received
    January 13, 2011
    Date of Event
    January 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    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. EVALUATION SUMMARY (B)(4) HELIX DISENGAGED FROM HELICAL CHANNEL, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD), BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE FIRST 6947 LEAD WAS ATTEMPTED BUT REQUIRED MULTIPLE REPOSITIONING ATTEMPTS TO GAIN "SATISFACTORY ELECTRICAL VALUES." AFTER THE MULTIPLE REPOSITIONING ATTEMPT THE HELIX WOULD NO LONGER EXTEND. A SECOND 6947 LEAD WAS ATTEMPTED. DURING THE IMPLANT OF THIS LEAD THE PATIENT WENT INTO AN EPISODE OF VENTRICULAR TACHYCARDIA. ANTI-TACHYCARDIA PACING VIA THE NEWLY IMPLANTED LEAD AS WELL AS EXTERNAL CARDIOVERSION WERE ATTEMPTED BUT WERE UNSUCCESSFUL RESULTING IN THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE FIRST 6947 LEAD WAS ATTEMPTED, BUT REQUIRED MULTIPLE REPOSITIONING ATTEMPTS TO GAIN "SATISFACTORY ELECTRICAL VALUES." AFTER THE MULTIPLE REPOSITIONING ATTEMPT THE HELIX WOULD NO LONGER EXTEND. A SECOND 6947 LEAD WAS ATTEMPTED. DURING THE IMPLANT OF THIS LEAD THE PATIENT WENT INTO AN EPISODE OF VENTRICULAR TACHYCARDIA. ANTI-TACHYCARDIA PACING VIA THE NEWLY IMPLANTED LEAD AS WELL AS EXTERNAL CARDIOVERSION WERE ATTEMPTED BUT WERE UNSUCCESSFUL RESULTING IN THE PATIENT'S DEATH. ADDITIONAL INFORMATION REPORTED IT WAS NOT BELIEVED THE DEATH WAS DEVICE RELATED. THE LEAD APPEARED TO ENTER THE RIGHT VENTRICLE WHICH CAUSED BRIEF RUN OF ECTOPICS. THIS IMMEDIATELY BECAME SUSTAINED VENTRICULAR TACHYCARDIA.

    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 54 YR Death| H| L| R