BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790657 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14157
    Event Type
    Injury
    Date Received
    October 15, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND THAT THE PROXIMAL CONDUCTOR FRACTURED. THERE WERE SEVERAL CONDUCTORS WITH BLOOD/BODY FLUID (NOT OBSTRUCTED) AND THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY. THE OUTER TUBING OVERLAY WAS MELTED AND BREACHED CUT. THE INNER AND OUTER INSULATION WAS BREACHED CUT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Additional Manufacturer Narrative · 1

    (B)(4) WE ALSO RECEIVED PRODUCT PERFORMANCE DATA FROM THE DEVICE AND ANALYZED THAT DATA. A LEAD INTEGRITY ALERT TRIGGERED FOR HIGH IMPEDANCE. THERE WERE TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 AND A PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. THE DAILY PACE LEAD IMPEDANCE TREND DATA SHOWED AND ABRUPT INCREASE FOR VENTRICULAR PACE BI-POLAR IMPEDANCE EQUAL TO 532 TO 4047 OHMS, (B)(6) 2012. NON-PHYSIOLOGIC OVERSENSING WAS NOTED. THERE WERE 15 VENTRICULAR NON-SUSTAINED TACHYCARDIA EVENTS LESS THAN OR EQUAL TO 190MS ON (B)(6) 2012. INTERFERENCE/NOISE WAS NOTED WITH A VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 779 COUNTS IN 3.87 DAYS BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED AND THE LEAD INTEGRITY ALERT TRIGGERED DUE TO HIGH IMPEDANCE, A HIGH NUMBER OF SHORT V-V COUNTS AND A LOT OF NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. 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 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB