BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2368393 · Received December 12, 2011

    Report

    Report Number
    2649622-2011-17224
    Event Type
    Injury
    Date Received
    December 12, 2011
    Date of Event
    September 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY FOR (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. A REVIEW OF THE SAVE TO DISK FOUND THE LEAD INTEGRITY ALERT TRIGGERED AND PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011. THERE WAS ALSO OVERSENSING WITH VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) LESS THAN EQUAL TO 210 MS ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 01:28:48 AND 01:29:31. VENTRICULAR FIBRILLATION (VF) LESS THAN EQUAL TO 160 MS AVERAGE V-CYCLE ON (B)(6) 2011 AT 15:47:44 AND 15:53:49. INTERFERENCE/NOISE WITH VENTRICULAR SHORT INTERVAL COUNT (V-SIC) EQUAL 34.5 COUNTS AVG/DAY, IN 2.00 DAYS, BETWEEN (B)(6) 2011 17:45:45 AND (B)(6) 2011 17:47:41.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN TWO DAYS OF IMPLANT THE LEAD INTEGRITY ALERT WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD HAVING OVERSENSING AND NOISE. THE POCKET WAS REOPENED TO CHECK THE LEAD IN THE DEVICE HEADER, ALL TESTING WAS OKAY AND THE LEAD PIN WAS NOT PULLED OUT OF THE HEADER. THE PHYSICIAN SUSPECTED THE EVENT WAS DUE TO AN ELECTROMAGNETIC INTERFERENCE THAT COULD NOT BE EXPLAINED. THE RV 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB