BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2953027 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00860
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DATA REVEALED THAT THERE WAS OVERSENSING OF THE RIGHT VENTRICULAR (RV) LEAD AND THAT THE LEAD INTEGRITY ALERT (LIA) HAD BEEN TRIGGERED. THERE WAS NON-PHYSIOLOGIC/ SIC (SHORT INTERVAL COUNTS) OVERSENSING ALSO. IT WAS NOTED THAT THERE WERE TWO PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 AT 07:42:35 AND 21:20:15. THERE WERE THREE LFP HIGH RATE-NS (NON-SUSTAINED) LESS THAN OR EQUAL TO 207 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012 19:52:21 AND (B)(6) 2012 08:12:49. THE VENTRICULAR SHORT INTERVAL COUNT(V-SIC) EQUALED 166 COUNTS, IN 2.97 DAYS, BETWEEN (B)(6) 2012 14:38:39 AND (B)(6) 2012 13:52:05.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR OVERSENSING ON THE RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT THERE WAS NOISE, NSVT (NON-SUSTAINED VENTRICULAR TACHYCARDIA), AND SHORT INTERVAL COUNTS (SIC) ON THE LEAD. IT IS SUSPECT OF A POSSIBLE CONNECTION ISSUE BETWEEN THE LEAD AND THE DEVICE. IT WAS FURTHER NOTED THAT THE LEAD HAD INCREASING THRESHOLDS, DECREASING SENSING AMPLITUDES, AND WAS SUSPECT TO THE START OF LEAD DISLODGEMENT. THE SENSING VECTOR WAS CHANGED AND LEAD REMAINS IN USE UNTIL THE PATIENT'S SCHEDULED LEAD REPLACEMENT PROCEDURE IN (B)(6) TAKES PLACE. THE DEVICE ALSO REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57739 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6932

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R D354VRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB