BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153741 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06187
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE EXPOSED SVC DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THE EXPOSED RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE EXPOSED RV DEFIBRILLATION COIL BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO MELTING, THE OVERLAY TUBING OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE, THE LEAD SEGMENTS THAT WERE RETURNED WERE THOROUGHLY ANALYZED ELECTRICALLY AND VISUALLY (INCLUDING DESTRUCTIVE ANALYSIS) IN AN ATTEMPT TO FIND THE EXPLANATION FOR "HIGH IMPEDANCE AND MULTIPLE SHORT V-V COUNTS" DESCRIBED IN THE EVENT. RESULTS FOR ALL ELECTRICAL TESTING WERE WITHIN SPECIFIED PARAMETERS. ALTHOUGH THE LEAD WAS RETURNED WITH EXPLANT DAMAGE, NO OTHER ANOMALIES WERE DISCOVERED REGARDING THE LEAD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT FOR HIGH IMPEDANCE AND MULTIPLE SHORT V-V COUNTS. THE PACE/SENSE PORTION OF THE LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254916 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 7227CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR