BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3071652 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05248
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. D224DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD),  IMPLANTED: (B)(6) 2010; 18 5076 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6 2010. (B)(4). EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR ANALYSIS, BUT WE DID RECEIVE PERFORMANCE DATA AND HAVE ANALYZED IT. THREE NON-SUSTAINED TACHYCARDIA EPISODES OF <(><<)> 220 MSEC V-V CYCLE ARE OBSERVED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED INTERMITTENT UNDERSENSING. THE LEAD 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
    171441 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR