BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922008 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12720
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 IN SEGMENTS. ANALYSIS RESULTS REVEALED THAT THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. BLOOD/BODY FLUID WAS PRESENT ON THE OUTER TUBING OVERLAY, AND IN/ON THE HELIX MECHANISM. THE DEFIB CONDUCTOR WAS DISTORTED. THE OUTER TUBING OVERLAY WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKS, AND WAS BREACHED CUT. THERE WAS A COSMETIC DEPRESSION IN THE OUTER INSULATION.

    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 IN SEGMENTS. ANALYSIS RESULTS REVEALED THAT THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. BLOOD/BODY FLUID WAS PRESENT ON THE OUTER TUBING OVERLAY, AND IN/ON THE HELIX MECHANISM. THE DEFIB CONDUCTOR WAS DISTORTED. THE OUTER TUBING OVERLAY WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKS, AND WAS BREACHED CUT. THERE WAS A COSMETIC DEPRESSION IN THE OUTER INSULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD REQUIRED REVISION DUE TO DECREASED SENSING, HIGH CAPTURE THRESHOLD, AND IMPEDANCE DECREASE. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE LEAD REQUIRED REVISION DUE TO DECREASED SENSING, HIGH CAPTURE THRESHOLD, AND IMPEDANCE DECREASE. SUBSEQUENT FOLLOW-UP DETERMINED THAT INCOMING INFORMATION WAS INCORRECTLY ATTRIBUTED TO THIS EVENT. UPON FURTHER REVIEW, IT WAS REPORTED THAT THE LEAD HAD DECREASED RIGHT VENTRICULAR SENSITIVITY AND THAT IT WAS EXPLANTED AND REPLACED DUE TO AN UPGRADE TO A BI-VENTRICULAR DEFIBRILLATION SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 65 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD