BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153177 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05856
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE DISTAL LV ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE LEAD INTEGRITY ALERT (LIA) TRIGGERED. LIA TRIGGERED ON (B)(6) 2013 DUE TO MEETING THE CONDITIONS FOR NON-SUSTAINED TACHYCARDIA (NST) AND VENTRICULAR SHORT INTERVAL COUNTS (SIC). ALSO THERE WAS NON-PHYSIOLOGICAL OVERSENSING WITH 3 NST, 1 VENTRICULAR FIBRILLATION AND 5 "LEAD FAILURE PREDICTOR" EPISODES OF LESS THAN 220 MS V-V CYCLE ARE RECORDED BETWEEN THE DATES OF (B)(6) 2013. THERE WAS GREATER THAN 10 V-SIC OCCUR PER DAY SINCE (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE ONE MONTH FOLLOW UP, INTERROGATION REVEALED THE RV LEAD R-WAVES HAD DROPPED AND NO PACING CAPTURE AT 8 VOLTS AT 1 MILLISECOND. THE LEAD TRENDS SUGGESTED DECREASED SENSING AND INCREASED THRESHOLD HAPPENED SOMETIME IN THE FIRST WEEK AFTER IMPLANT. THE RV LEAD WAS REPROGRAMMED UNTIL A LEAD REVISION. UNDER FLUOROSCOPY IT WAS SEEN THE RV LEAD HAD PULLED BACK FROM THE ORIGINAL POSITION. THE RV LEAD WAS REPOSITIONED AND HAD ACCEPTABLE ELECTRICAL TESTING. HOWEVER, WITHIN THREE DAYS OF THE LEAD REVISION THE RV LEAD HAD DISLODGED AGAIN DESPITE HAVING BEEN SUTURED WITH THREE SUTURE SLEEVES AND A LARGE STRESS RELIEF LOOP AT THE TIME OF THE PRIOR REVISION. THE RV 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
    256117 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR