BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2203023 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12060
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS REVEALED THAT THE HELIX HAD DISENGAGED FROM THE HELICAL CHANNEL. THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THE INNER TUBING WAS KINKED/BUCKLED. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD.

    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 FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS REVEALED THAT THE HELIX HAD DISENGAGED FROM THE HELICAL CHANNEL. THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD, AND THE HELIX/LOBE WAS DISTORTED/BENT. VISUAL COMMENT: LEAD INSULATION WAS CUT WITH A SCALPEL TO INJECT ALCOHOL TO REMOVE STYLET FROM THE DISTAL COIL WHICH WAS STUCK DUE TO DRIED BLOOD. THE LEAD WAS RETURNED WITH COMPRESSED HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT THE LEAD WAS INTRODUCED INTO THE VASCULATURE BETWEEN SEVERAL OTHER CHRONICALLY IMPLANTED LEADS CAUSING A TIGHT INTRODUCTION. ONCE IN THE RIGHT VENTRICLE THE LEAD HELIX WOULD NOT EXTEND. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    (B)(4)

    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 48 YR Other 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD