BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964435 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02073
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. LEAD INTEGRITY ALERT TRIGGERED: THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 15:00:06. SENSING - OVERSENSING: THERE WERE SIX VENTRICULAR NON SUSTAINED TACHYCARDIAS (NST) <(><<)>=190 MS BETWEEN (B)(6) 2012 15:37:30 AND (B)(6) 2012 11:06:30. SENSING - SICS SINCE LAST SESSION - INTERFERENCE/NOISE: VENTRICULAR SHORT INTERVAL COUNTS (V-SIC) =188 COUNTS, IN 30.23 DAYS, BETWEEN (B)(6) 2012 08:23:26 AND (B)(6) 2012 13:56:36.

    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 PRESENTED TO THE EMERGENCY ROOM (ER) AFTER THE RIGHT VENTRICULAR LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA). THE ALERT WAS TRIGGERED DUE TO A HIGH SENSING INTEGRITY COUNT AND INCREASING IMPEDANCE. 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
    67102 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention D224VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR