BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993324 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09377
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. CONCOMITANT MEDICAL PRODUCTS: 2088TC LEAD, (B)(6) 2012; 4196-88 LEAD, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED IN SEGMENTS. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WERE NO ANOMALIES OBSERVED REGARDING THE RETURNED LEAD. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. AN IN-VIVO IN SULATION BREACH OR CONDUCTOR FRACTURE WAS NOT OBSERVED DURING ANALYSIS. THE LEAD WAS RETURNED WITH NON-SEVERE EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS EARLIER THAN EXPECTED BATTERY LONGEVITY. IT WAS ALSO REPORTED THERE WAS RIGHT VENTRICULAR (RV) LEAD HIGH UNSTABLE THRESHOLDS. THE DEVICE AND RV WERE 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
    469584 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R D314TRM ICD