BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4162817 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12588
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 18, 2014
    Report Date
    July 19, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DEVICE 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. CONCOMITANT PRODUCT : 5076-45 LEAD, IMPLANTED 2003-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THE MAXIMUM VENTRICULAR PACING IMPEDANCE ROSE FROM 437 OHMS THE WEEK ENDING (B)(6) 2014 TO GREATER THAN 4000 OHMS THE WEEK ENDING (B)(6) 2014. EIGHT (8) NON-SUSTAINED TACHYCARDIA EVENTS WITH A V-V CYCLE LENGTH OF LESS THAN 220 MILLISECONDS WERE RECORDED BETWEEN (B)(6) 2014. A HIGH IMPEDANCE ALERT WAS TRIGGERED ON (B)(6) 2014.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET (POR) DUE TO A WRITE TO LOCKED RANDOM ACCESS MEMORY (RAM). AN ALERT WAS ISSUED BUT THE PATIENT WAS UNAWARE OF THE DEVICE BEEPING. THE POR WAS CLEARED WHEN THE DEVICE WAS REPROGRAMMED AND IT WAS NOTED THAT THE DEVICE WAS NEARING RECOMMENDED REPLACEMENT TIME (RRT). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING AND THE ELECTROGRAM (ECG) SHOWED BRIEF PERIODS OF ASYSTOLE. THE LEAD WAS EVALUATED FOR REPLACEMENT HOWEVER THE IMPEDANCE AND CAPTURE THRESHOLD TRENDS WERE STABLE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD REMAINS 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
    639741 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Hospitalization| L| R 4194-88 LEAD, D224TRK ICD