BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3860628 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05367
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 23, 2013
    Report Date
    April 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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: 5076-52 LEAD, (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS THAT WERE VERY PAINFUL AND HAD TO "GET RUSHED TO THE EMERGENCY ROOM". THE PATIENT STATED "I UNDERWENT SURGERY AND IT WAS [DETERMINED] THE COILS WERE LEAKING AND RUSTY." IT WAS FURTHER REPORTED THAT DURING THE DEVICE CHANGE-OUT FOR END OF LIFE (EOL) THE RIGHT VENTRICULAR (RV) LEAD WAS UNDERSENSING R-WAVES, WHICH LED TO T-WAVE OVERSENSING (TWOS) AND INAPPROPRIATE SHOCKS. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND ANOTHER LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340374 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L| R D154ATG ICD