BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4833598 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07026
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    November 19, 2014
    Report Date
    April 22, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS PRODUCT WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING INFORMATION. RV LEAD INTEGRITY ALERT WARNING FOR INCREASED SIC COUNT AND 2 OR MORE VT-NS EPISODES <(><<)>220 MS ON (B)(4) 2015. EVIDENCE OF OVERSENSING HAS BEEN NOTED DURING VT-NS EPISODES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR A SUSPECTED FRACTURE. THE LEAD EXHIBITED OVERSENSING, NOISE, AND ELEVATED SHORT INTERVAL COUNTS (SIC). A TRANSMISSION SHOWED T-WAVE OVERSENSING (TWOS) POST PVC. THE PHYSICIAN STATED THAT THE APPARENT OVERSENSING ON THE ELECTROGRAM TRACINGS COULD HAVE BEEN FROM A SHORT IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE ITSELF. A CLINICAL COURSE OF ACTION HAS NOT BEEN DECIDED. THE LEAD AND DEVICE REMAIN 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
    374846 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR D284DRG ICD, 1688 ST JUDE LEAD