BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2812527 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16450
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE IMPEDANCE: MAX RV PACE LEAD IMPEDANCE RISES FROM 800 TO 4032 OHMS BETWEEN THE WEEKS OF (B)(6) 2012. SENSING-SICS SINCE LAST SESSION - INTERFERENCE/NOISE: LIFETIME V-SIC COUNTER IS AT 1359.7, 473 OF THESE COUNTS HAVING OCCURRED SINCE (B)(6) 2012. ALERT - HIGH RESISTANCE/IMPEDANCE: OUT OF TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE ALERT REGISTERED ON (B)(6) 2012. LIA NOT INSTALLED ON THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD CARDIO-VERSION. THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR INCREASED IMPEDANCE WHICH PEAKED AT A HIGH IMPEDANCE MEASUREMENT. OVERSENSING OF THE ATRIUM AND NOISE WAS NOTED. THE PACE/SENSE AND RV COIL WERE CAPPED AND THE SUPERIOR VENA CAVA COIL 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
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB