BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2783821 · Received October 11, 2012

    Report

    Report Number
    2649622-2012-13371
    Event Type
    Injury
    Date Received
    October 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ACTUAL LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND THE DATA HAS BEEN ANALYZED. RESISTANCE/IMPEDANCE INCREASE: WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MAX VENTRICULAR PACE BI IMPEDANCE = 380 TO 1425 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012. LEAD INTEGRITY ALERT TRIGGERED: 1-1 PATIENT ALERT FOR LEAD FAILURE PREDICTOR BETWEEN (B)(6) 2102 09:0:04 AND (B)(6) 2012 14:31:30. SENSING/OVERSENSING: 14 - VENTRICULAR NST <=320 MS BETWEEN (B)(6) 2012 04:14:31 AND (B)(6) 2012 14:32:22. INTERFERENCE/NOISE: VENTRICULAR SHORT INTERVAL COUNT V-SIC=92.4 COUNTS AVG/DAY, IN 1.19 DAYS, BETWEEN (B)(6) 2012 10:41:27 AND (B)(6) 2012 15:16:11. THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS FRACTURED, AND BLOOD/BODY FLUID WAS PRESENT (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING, BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM, AND THE HELIX/LOBE WAS DISTORTED/BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT AND THAT THE RIGHT VENTRICULAR LEAD HAD INCREASED IMPEDANCE, NOISE, AND OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. 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 70 YR Hospitalization| R