BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990642 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08549
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : FURTHER PERFORMANCE DATA ABOUT THE LEAD 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 3287 OHMS THE WEEK ENDING (B)(6) 2014. OVERSENSING WAS OCCURRING; THERE WERE 12 NON-SUSTAINED TACHYCARDIA EPISODES WITH A V-V CYCLE LENGTH OF LESS THAN 220 MILLISECONDS RECORDED ON (B)(6) 2014. INTERFERENCE/NOISE WAS ALSO RECORDED STARTING (B)(6) 2014 WITH 2329 OF 3175 LIFETIME VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) OCCURRING. LEAD INTEGRITY ALERTS WERE TRIGGERED ON (B)(6) 2014 AND (B)(6) 2014 DUE TO IMPEDANCE AND V-SIC.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE THRESHOLD HAD BEEN SLOWLY RISING OVER THE PAST YEAR.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE THEIR DEVICE WAS TONING. THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO PACE/SENSE IMPEDANCE VARIATION, ELEVATED SIC, AND NON-PHYSIOLOGIC NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. THERE WAS ALSO INTERMITTENT OVERSENSING, NOISE, AND A SUSPECTED LEAD FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468357 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R D224VRC ICD