BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991560 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08049
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. MODEL: 407645, LEAD; IMPLANT: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEFIBRILLATION THERAPY FAILED DURING A VT EPISODE. DURING A LEAD REPOSITION/REVISION PROCEDURE TO GET BETTER DEFIBRILLATION THRESHOLDS (DFT) THE HELIX OF THE RIGHT VENTRICULAR (RV) LEAD WOULD NOT EXTEND AFTER MULTIPLE ATTEMPTS. THE LEAD WAS REMOVED AND THE HELIX MECHANISM WAS STILL UNABLE TO BE EXTENDED. THE PHYSICIAN DECIDED TO REPLACE THE LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470596 SPRINT QUATTRO SECURE DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R (B)(4), ICD