BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991539 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02428
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 6, 2011
    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
    NM, US
    Reporter Occupation
    RISK MANAGER

    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. A VOLUNTARY MEDWATCH FORM 3500 WAS RECEIVED. TRIAGE UNIT SEQUENCE (B)(4). EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. ADDITIONAL FINDINGS OF DEFIB CONDUCTOR DISTORTED, SEVERAL CONDUCTORS CUT, BLOOD/BODY FLUID OUTER TUBING OVERLAY, INNER AND OUTER TUBING KINKED/BUCKLED, EXPOSED DEFIB COIL WHITE SUBSTANCE, BLOOD IN/ON HELIX MECHANISM, STYLET STUCK IN LEAD-DISTAL COIL, LEAD STRETCHED AND APPARENT EXPLANT DAMAGE. ALSO OUTER TUBING OVERLAY MELTED, COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION TORN, BREACHED CUT AND COSMETIC DEPRESSION. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. TRIAGE UNIT SEQUENCE # (B)(4). ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DELIVERED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING. A MEDWATCH 3500 FURTHER REPORTED THAT THERE HAD BEEN AN ABRUPT DECREASE IN R-WAVES WITH P-WAVE OVERSENSING, AND THAT THE PATIENT WAS CONVERTED TO INTEGRATED BIPOLAR SENSING TO TEMPORARILY PRECLUDE FURTHER SHOCKS. THE LEAD WAS LATER EXPLANTED AND REPLACED, AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DELIVERED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING. A MEDWATCH 3500 FURTHER REPORTED THAT THERE HAD BEEN AN ABRUPT DECREASE IN R-WAVES WITH P-WAVE OVERSENSING, AND THAT THE PATIENT WAS CONVERTED TO INTEGRATED BIPOLAR SENSING TO TEMPORARILY PRECLUDE FURTHER SHOCKS. THE LEAD WAS LATER EXPLANTED AND REPLACED, AND NO FURTHER 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 60 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD