BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2811205 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16099
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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) - PERFORMANCE DATA WAS RETRIEVED FROM THE DEVICE AND HAS BEEN ANALYZED. LEAD INTEGRITY ALERT TRIGGERED: PROGRAMMER DATA SHOWS 2 - RV - LEAD INTEGRITY ALERTS ON (B)(4) 2012 AT 07:05:06 AND 14:47:16. ONE - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 AT 07:05:06 AND 14:47:16. HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 02:15:04 AND 2012 02:15:04. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MAX RV PACE = 340 TO INF(UN-FILTERED DATA) OHMS PEAK BETWEEN (B)(4) 2012. SENSING/OVERSENSING: 14 - VENTRICULAR NST <=210 MS ON (B)(4) 2012 IN THE TIMEFRAME BETWEEN 14:07:12 AND 14:48:33. 11 - VF<=200 MN AVERAGE V-CYCLE ON (B)(4) 2012 IN THE TIMEFRAME BETWEEN 09:11:06 AND 14:05:33. INTERFERENCE/NOISE: VENTRICULAR SHORT INTERVAL COUNT V-SCI=1764.5 COUNTS AVG/DAY, IN 3.95 DAYS, BETWEEN (B)(4) 2012 10:55:15 AND (B)(4) 2012 09:48:20. THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS FRACTURED. THE OUTER TUBING OVERLAY EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING, AND THE OUTER INSULATION EXHIBITED A COSMETIC DEPRESSION. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE MECHANISM (SLEEVE HEAD).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED 24 INAPPROPRIATE SHOCKS, AND THE LEAD INTEGRITY ALERT (LIA) TRIGGERED. THE LEAD EXHIBITED NOISE, OVERSENSING, HIGH IMPEDANCES, AND HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R D144VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB