BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3993528 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09250
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    March 14, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HISTORICAL EPISODES OF T-WAVE OVERSENSING (TWOS) WERE OBSERVED DURING THE INTERROGATION OF THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS ALSO REPORTED THAT THE PATIENT WAS UNDERGOING REHABILITATION DURING THE ISOLATED PERIOD OF THE RECORDED EPISODES AND THAT THE INCREASED ACTIVITY MAY HAVE BEEN ASSOCIATED WITH THE TWOS. SUBSEQUENT AND REAL TIME ELECTROGRAM (EGM) DATA ON THE DAY OF THE INTERROGATION DID NOT SHOW ANY EVIDENCE OF THE TWOS. NO INTERVENTION OR REPROGRAMMING WAS PERFORMED AT THE TIME. THE DEVICE AND LEAD SYSTEM REMAINS 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
    472174 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR D274DRG DEVICE