BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1925650 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13976
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 23, 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
    SP
    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): THE FULL LEAD WAS RETURNED WHERE IT WAS DISCOVERED THAT THE DISTAL CONDUCTOR WAS FRACTURED. THE INNER TUBING WAS KINKED/BUCKLED AT VARIOUS LOCATIONS THROUGHOUT THE LEAD. THERE WAS BLOOD/BODY FLUID IN/ON THE HELIX, THE SLEEVEHEAD AND THE OUTER OVERLAY TUBING NEAR THE CONNECTOR. THERE WERE CUTS AND MELTED INSULATION OBSERVED ON THE OUTER INSULATION OF THE IS-1 CONNECTOR LEG. NEAR THE CONNECTOR, THE OUTER INSULATION WAS BREACHED DUE TO CUTS AND HAD COSMETIC DEPRESSION. THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL. TIP SEAL OBSERVATION.

    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. 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 PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS DURING THE LEAD REVISION. THE LEAD HAD HIGH IMPEDANCE, WAS OVERSENSING, AND THE LEAD INTEGRITY ALERT HAD TRIGGERED. THE LEAD WAS REMOVED AND REPLACED. 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 Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB