BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812188 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16662
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    January 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE EXPOSED SUPERIOR VENA CAVA (SVC) CONDUCTOR COIL WAS FRACTURED FROM FLEX. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED FROM OVER-ROTATION, THE DISTAL END LOW VOLTAGE ELECTRODE WAS COVERED IN BLOOD, THE DISTAL END ELECTRODES WERE PULLED/STRETCHED/OVERSTRESSED AND THE HELIX WAS BENT. ALSO THE OUTER TUBING OVERLAY INSULATION WAS BREACHED FROM MELTING AND THE OUTER TUBING OVERLAY INSULATION HAD BLOOD INGRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH THRESHOLDS AND LOW SENSING VALUES OBSERVED IN THE RIGHT VENTRICULAR LEAD. IT WAS ALSO REPORTED THAT DURING THE LEAD REPOSITIONING PROCEDURE, THE HELIX WOULD NOT RE-EXTEND DURING AN ATTEMPT TO REPOSITION THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD