BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2205560 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12018
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    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): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 6 - PATIENT ALERTS FOR RV PACING LEAD IMPEDANCE BETWEEN (B)(6) 2009 AND (B)(6) 2011. DAILY PACE LEAD IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR V.PACE= 616 TO 3216 OHMS PEAK BETWEEN (B)(6) 2011. 50 - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=180 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 10:19:49 AND 15:22:16. VENTRICULAR SHORT INTERVAL COUNT V-SIC=115.3 COUNTS AVG/DAY, IN 6.68 DAYS, BETWEEN (B)(6) 2011 16:38:17 AND (B)(6) 2011 07:51:30. DISTAL CONDUCTOR FRACTURED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WERE OVER 700 SHORT INTERVALS, WHICH COULD INDICATE OVERSENSING, HIGH PACING IMPEDANCE GREATER THAN 1500 OHMS, AND MANY NON-SUSTAINED TACHYCARDIA (NST) 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 Hospitalization| R 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB