BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992515 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09836
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS WORKING IN THEIR SHOP AND HAD RECEIVED EIGHT SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT REPORTED THAT THEY HAD HEARD AN ALERT TONE FROM THE DEVICE. THE PATIENT REPORTED TO THE EMERGENCY ROOM FOR DEVICE INTERROGATION WHERE HIGH IMPEDANCE VALUES WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. EVALUATION OF THE PATIENT CONFIRMED A FRACTURE OF THE RV LEAD. THE LEAD WAS SUBSEQUENTLY REPLACED AND DURING THE SURGICAL PROCEDURE IT WAS DETERMINED THAT THE LEAD FRACTURE WAS LOCATED IN THE POCKET REGION. IT WAS REPORTED THAT THE PATIENT'S PHYSICAL ACTIVITY HAD PUT PRESSURE ON AND MOVED THEIR DEVICE CAUSING THE LEAD TO FRACTURE. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467304 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R D314VRG DEVICE