BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992188 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10017
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. PRODUCTS: 5076-45 LEAD 2003 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN AUDIBLE ALERT NOTED BY THE PATIENT ONE DAY POST IMPLANT. INTERROGATION AND CHEST X-RAY PERFORMED BY THE PHYSICIAN CONFIRMED THAT THERE WAS A HIGH VOLTAGE (HV) SET SCREW ISSUE. THE PHYSICIAN DECIDED TO DO A RIGHT VENTRICULAR (RV) LEAD REVISION TO RECONNECT THE HV COIL. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV LEAD REMAIN 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
    468943 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R (B)(4) ICD