BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812380 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03814
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR MAX VENTRICULAR PACE BI IMPEDANCE = 418 TO 988 OHMS PEAK BETWEEN (B)(6) 2012, THEN RETURNING TO 437 OHMS ON (B)(6) 2012. ONE - PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2012, 07:22:37. 15 - VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF <=210 MS OCCURRED ON (B)(6) 2012, IN THE TIMEFRAME BETWEEN 09:35:04 AND 09:58:49. 29 VENTRICULAR FIBRILLATION EPISODE OF <=210 MS AVERAGE V-CYCLE OCCURRED BETWEEN (B)(6) 2012, 11:44:07 AND (B)(6) 2012, 09:36:07. VENTRICULAR SHORT INTERVAL COUNT V-SIC=55.9 COUNTS AVG/DAY, IN 47.49 DAYS, BETWEEN (B)(6) 2012, 22:17:54 AND (B)(6) 2012, 10:05:50.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS DUE TO OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE DEVICE ALARM HAD BEEN GOING OFF FOR TWO OR THREE WEEKS. AN IMPEDANCE SPIKE WAS ALSO NOTED ON INTERROGATION. THE LEAD WAS POSSIBLY FRACTURED. X-RAY ALSO DETERMINED THAT TWO LEAD CONNECTORS WERE NOT FULLY INSERTED INTO THE DEVICE PORT. HIGH VOLTAGE THERAPIES WERE TURNED OFF. THE DEVICE AND LEAD REMAIN IN USE. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R