BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922824 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13094
    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
    TN, 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) ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. (B)(4) ANALYSIS REVEALED THE LEAD WAS STRETCHED; THE FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED THAT THE INNER INSULATION WAS KINKED/BUCKLED, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS ALSO NOTED THAT THE LEAD HAS BEEN STRETCHED SUCH THAT THE INNER TUBING BUCKLED, PREVENTING THE HELIX FROM FUNCTIONING PROPERLY.

    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 NO ANOMALIES WERE FOUND. THERE WAS BLOOD IN/ON THE HELIX AND SLEEVEHEAD. THERE WAS COSMETIC DEPRESSIONS ON THE OUTER INSULATION NEAR THE CONNECTOR AND COSMETIC ENVIRONMENT STRESS CRACKS ON THE OUTER OVERLAY TUBING. (B)(4) ANALYSIS REVEALED THE LEAD WAS STRETCHED; THE FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED THAT THE INNER INSULATION WAS KINKED/BUCKLED, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS ALSO NOTED THAT THE LEAD HAS BEEN STRETCHED SUCH THAT THE INNER TUBING BUCKLED, PREVENTING THE HELIX FROM FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH THRESHOLDS ON THE ATRIAL LEAD. DURING A DEVICE CHANGE OUT FOR MEDICAL JUDGMENT/SYSTEM UPGRADE, IT WAS NOTED THAT THE ATRIAL AND VENTRICULAR LEADS WERE DISLODGED. THE LEADS WERE UNABLE TO BE REPOSITIONED AND THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. 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 38 YR Hospitalization| R