BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2525925 · Received April 10, 2012

    Report

    Report Number
    2649622-2012-02879
    Event Type
    Malfunction
    Date Received
    April 10, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE WAS OVERSENSING SEEN WITH ONE VENTRICULAR NON SUSTAINED TACHYCARDIA EQUAL TO 210 MS ON (B)(4) 2011 12:36:56. IN ADDITION THERE WAS INTERFERENCE/NOISE AS BY VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 104 COUNTS, IN 1.0 DAY, BETWEEN (B)(4) 2011 16:25:38 AND (B)(4) 2011 16:18:34. THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SAVE TO DISK WAS RECEIVED, ANALYZED AND THERE WAS AN OUT OF SPECIFICATION FINDING ON THE LEAD. 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 SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB