BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811283 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16596
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYSIS FOUND THAT THE OUTER INSULATION HAD BI/MULTI-LUMEN TUBING VOIDS. THE LEAD'S OUTER INSULATION WAS BREACHED/CUT AND THE INSULATION OVERLAY TUBING HAD BLOOD INGRESSION. THE DEFIBRILLATOR SUPERIOR VENA CAVA CONDUCTOR WAS KINKED/BUCKLED. THE OUTER INSULATION HAS A COSMETIC DEPRESSION AND THE OVERLAY TUBING HAS ENVIRONMENTAL STRESS CRACKING. THE DISTAL ELECTRODE WAS COVERED IN BLOOD. THE LEAD'S SUPERIOR VENA CAVA CONDUCTOR WAS PULLED/STRETCHED DUE TO OVERSTRESS. THE OUTER TUBING OVERLAY WAS BREACHED/CUT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES THAT INDICATED NOISE. A FRACTURE WAS SUSPECTED. THE LEAD 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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5071 IMPLANTABLE PACING LEAD