BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 4162946 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12550
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 16, 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 LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DATA INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. THE RV DEFIBRILLATION IMPEDANCE WAS STEADY AT 45 OHMS THROUGH (B)(6) 2014, ROSE OUT OF RANGE (GREATER THAN 120 OHMS) STARTING (B)(6) 2014. DAILY IMPEDANCE VARIES BETWEEN 18 AND 180 OHMS OVER THE PREVIOUS TWO WEEKS.

    Additional Manufacturer Narrative · 1

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

    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. CONCOMITANT MEDICAL PRODUCTS: D164AWG IPG, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT TRIGGERED DUE TO THE HIGH DEFIBRILLATION LEAD IMPEDANCE OF THE RV COIL AND THE SVC COIL. THE RIGHT VENTRICULAR (RV) LEAD SETTING WAS ADJUSTED AND THE LEAD REMAINED IN USE UNDER OBSERVATION. IT WAS REPORTED THAT ANOTHER LEAD INTEGRITY ALERT TRIGGERED DUE TO HIGH RV IMPEDANCE. IN ADDITION IT WAS REPORTED THAT THE RV COIL IMPEDANCE HAD BEEN UNSTABLE SINCE THE PREVIOUS CHECK. THE RV LEAD WAS PLANNED FOR EXTRACTION AT AN UNSPECIFIED TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639276 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R 6940 LEAD