BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3861282 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07320
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). BEGINNING (B)(6) 2014 SHORT INTERVAL COUNTS (SIC) WERE 247 WITH MULTIPLE EPISODES OF LEAD NOISE/OVERSENSING. ANALYSIS OF THE DEVICE MEMORY INDICATED THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) OCCURRED. ON (B)(6) 2014, THE LIA FOR RV LEAD PACING IMPEDANCE OF GREATER THAN 2500 OHMS OCCURRED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV PACING LEAD WAS VARIABLE. RV PACING LEAD IMPEDANCE WAS VARIABLE FROM 528 OHMS TO 1120 OHMS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: D154AWG, ICD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE AND POSSIBLY FRACTURED. A NEW LEAD WAS IMPLANTED TO HANDLE THE PACE/SENSE ACTIVITIES AND THE LEAD REMAINS IN USE FOR THE HIGH VOLTAGE COILS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339438 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R 5076-45, LEAD