BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2051972 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05698
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING WAS NOTED AS SIXTEEN VENTRICULAR NST<=210 MS AVERAGE V-CYCLE BETWEEN (B)(6)2009 AND (B)(6) 2011 AND ONE VF = 210 MS ON (B)(6) 2008. INTERFERENCE/NOISE WAS ALSO OBSERVED AS THE VENTRICULAR SHORT INTERVAL COUNT V-SIC=27.0 COUNTS AVG/DAY, IN 17 DAYS, BETWEEN (B)(6) 2011 AND (B)(6) 2011. ADDITIONALLY, PROGRAMMER DATA SHOWS LEAD INTEGRITY ALERT TRIGGERED ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT WAS TRIGGERED DUE TO OVERSENSING AND NOISE THAT COULD BE REPRODUCED VIA MOVEMENT. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. THE HIGH VOLTAGE PORTION OF 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
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD