BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810864 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16317
    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
    MD, 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) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. SEVERAL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE INNER TUBING OVERLAY WAS MELTED. THE OUTER TUBING OVERLAY WAS MELTED. THE OUTER INSULATION HAD COSMETIC DEPRESSION. VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD VENTRICULAR TACHYCARDIA EVENTS. THE RIGHT VENTRICULAR LEAD TRIGGERED A LEAD INTEGRITY ALERT FOR OVERSENSING. ELECTROGRAM SHOWED APPARENT NOISE. FLUOROSCOPY SHOWED THAT THE PROXIMAL END OF SUPERIOR VENA CAVA COIL WAS COMPLETELY AND VISIBLY FRACTURED WITH SEVERAL SMALL COILS PROTRUDING FROM THE LEAD. LASER EXTRACTION OF THE LEAD WAS ATTEMPTED, BUT THE STYLET WAS UNABLE TO BE ADVANCED DOWN THE LUMEN OF THE LEAD. NEW ACCESS WAS GAINED AND A NEW LEAD WAS IMPLANTED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD