BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3863474 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06722
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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). ANALYSIS OF THE DEVICE MEMORY ALSO INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET AND INDICATED A LEAD NOISE ALERT. 8982 OF 8983 LIFETIME VENTRICULAR SIC ARE RECORDED BEGINNING (B)(6) 2014. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(6) 2014 DUE TO MEETING THE REQUIREMENTS FOR NON-SUSTAINED TACHYCARDIA EPISODES AND VENTRICULAR SIC. A PATIENT ALERT OCCURRED ON (B)(6) 2014 FOR LEAD NOISE.

    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: PRODUCT ID: 5594 LEAD, IMPLANTED: (B)(6) 2008. A PRODUCT ID: D364TRG ICD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DELIVERED INAPPROPRIATE SHOCKS DUE TO HIGH SHORT INTERVAL COUNTS (SIC) AND A HIGH NUMBER OF NON-SUSTAINED TACHYCARDIA EPISODES. THE RV LEAD HAD A SUDDEN INCREASE IN IMPEDANCE AND A FRACTURE WAS SUSPECTED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE HAD A SUDDEN INCREASE AND WAS HIGH. THE RV AND LV LEADS WERE CAPPED. THE RV LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338613 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| L| R 4193 LEAD