BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810810 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16553
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MPRI
    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 Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS ALSO RECEIVED AND ANALYZED. OVERSENSING WAS NOTED AS 13 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES <(><<)>=210 MS OCCURRED BETWEEN (B)(6) 2012 21:32:05 AND (B)(6) 2012 01:26:35. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS THREE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED BETWEEN (B)(6) 2012 02:15:03 AND (B)(6) 2012 02:15:06. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA NOTED AN ABRUPT INCREASE FOR RV PACE FROM 416 TO 2704 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012. NOISE WAS NOTED AS THE VENTRICULAR SHORT INTERVAL COUNT V-SIC WAS 19234 COUNTS, IN 12.68 DAYS, BETWEEN (B)(6) 2012 19:18:16 AND (B)(6) 2012 11:35:16. IT WAS ALSO NOTED THAT PROGRAMMER DATA SHOWS ONE RV LEAD INTEGRITY ALERT ON (B)(6) 2012 18:08:19. ADDITIONALLY, ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2012 18:08:19.

    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 IN SEGMENTS WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR HAD FRACTURED. IT WAS ALSO NOTED THAT ALL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. THE ANALYST ALSO NOTED THAT THE ANCHORING SLEEVE FIXATION SITE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUDDEN INCREASE IN THE IMPEDANCE ON THE VENTRICULAR LEAD. THE LEAD WAS OVERSENSING WITH A HIGH IMPEDANCE WHICH TRIGGERED A PATIENT ALERT. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUDDEN INCREASE IN THE IMPEDANCE ON THE VENTRICULAR LEAD. THE LEAD WAS OVERSENSING WITH A HIGH IMPEDANCE WHICH TRIGGERED A PATIENT ALERT. 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB