BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992178 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02410
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. MODEL: 407652, LEAD; IMPLANT: (B)(6) 2009; MODEL: 419488, LEAD. IMPLANT: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALERTING/BEEPING. UPON INTERROGATION IT WAS DISCOVERED THE RIGHT VENTRICULAR (RV) LEAD WAS EXPERIENCING HIGH/ERRATIC SVC COIL IMPEDANCE LEVELS AND HIGH/FLUCTUATING RV COIL IMPEDANCE LEVELS. AN X-RAY REVEALED AN RV LEAD CONNECTION PIN ISSUE. AN INTERVENTION WAS COMPLETED AND THE LEAD CONNECTOR PIN WAS RESEATED INTO THE DEVICE HEADER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470707 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R DTBA1D1, ICD