BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3991108 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08304
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVER-SENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) WERE MET. 652 OF 2423 LIFETIME VENTRICLE-SIC ARE RECORDED BEGINNING 2013-08-16. LIA TRIGGERED ON (B)(4) 2014 DUE TO MEETING THE REQUIREMENTS FOR NONSUSTAINED TACHYCARDIA (NST) AND VENTRICLE-SIC. THERE WERE 2 NST E VENTS OF LESS THAN 220 MILLISECONDS, VENTRICLE-VENTRICLE CYCLE RECORDED BETWEEN (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 5554-53 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) SOUNDED DUE TO NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT), AND SHORT INTERVAL COUNTS (SICS). INCREASED LEAD THRESHOLD AND RECURRENT NOISE WERE CONFIRMED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468704 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R D234DRG ICD