BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3153581 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06123
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO OVER-ROTATION. THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO PULLING/STRETCHING/OVERSTRESS. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. ANALYST COMMENTED OTHER THAN EXPLANT DAMAGE, NO ANOMALIES WERE OBSERVED REGARDING THE RETURNED FULL LEAD IN SEGMENTS. AN IN-VIVO INSULATION BREACH OR CONDUCTOR FRACTURE WAS NOT OBSERVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CONNECTING THE CHRONIC RIGHT VENTRICULAR (RV) LEAD TO THE NEWLY IMPLANTED DEVICE, THE LEAD SHOWED HIGHER IMPEDANCE AND NOISE ON NEAR-FIELD ELECTROGRAM (EGM) WHEN THE DEVICE WAS MOVED OR THE LEAD(S) WERE TOUCHED. IT WAS ALSO REPORTED THAT THERE WERE MULTIPLE ATTEMPTS TO RECONNECT THE RV LEAD TO THE DEVICE BUT THE NEAR-FIELD NOISE REMAINED. THE FOLLOWING DAY RV LEAD WAS REMOVED AND THE INNER PORTION OF THE LEAD CAME OUT. THE RV LEAD WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257055 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 69476536

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R