BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2448993 · Received February 13, 2012

    Report

    Report Number
    2649622-2012-00426
    Event Type
    Injury
    Date Received
    February 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE -PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2011 02:15:03. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MAX RV PACE = 592 TO INFINITE OHMS (UN-FILTERED DATA) PEAK BETWEEN (B)(4) 2011 AND (B)(4) 2011. ELEVEN - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS BETWEEN (B)(4) 2011 14:00:03 AND (B)(4) 2011 16:56:40. ONE - VF=180 MS AVERAGE V-CYCLE (B)(4) 2011 10:14:06. VENTRICULAR SHORT INTERVAL COUNT V-SIC=421.4 COUNTS AVG/DAY, IN 20.74 DAYS, BETWEEN (B)(4) 2011 16:39:47 AND (B)(4) 2011 10:19:40.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, HIGH PACING IMPEDANCE GREATER THAN 2500 OHMS WAS NOTED, ALONG WITH OVER 8000 SHORT INTERVALS WHICH COULD INDICATE OVERSENSING. THE LEAD WAS REPLACED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R