BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2449930 · Received February 14, 2012

    Report

    Report Number
    2649622-2012-00571
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    July 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THAT COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR (LFP) ON (B)(6) 2011 16:43:38. 2 - LFP HIGH RATE-NS <= 215 MS AVERAGE V-CYCLE ON (B)(6) 2011 17:41:28 AND (B)(6) 2011 13:16:32. VENTRICULAR SHORT INTERVAL COUNT V-SIC=3.1 COUNTS AVG/DAY, IN 33.10 DAYS, BETWEEN (B)(6) 2011 10:12:55 AND (B)(6) 2011 12:39:53.

    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'S 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 THAT COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ONE - PATIENT ALERT FOR LEAD FAILURE PREDICTOR (LFP) ON (B)(6) 2011 16:43:38. ONE - LFP HIGH RATE-NS <= 215 MS AVERAGE V-CYCLE ON (B)(6) 2011 17:41:28 AND (B)(6) 2011 13:16:32. VENTRICULAR SHORT INTERVAL COUNT V-SIC=3.1 COUNTS AVG/DAY, IN 33.10 DAYS, BETWEEN (B)(6) 2011 10:12:55 AND (B)(6) 2011 12:39:53.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL FOLLOWING LIA (LEAD INTEGRITY ALERT). SHORT V-V INTERVALS, WHICH COULD INDICATE OVERSENSING, WERE NOTED. A POSSIBLE REVISION OF THE LEAD WAS NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LEAD TREND SHOWED NORMAL VARYING ON THE RIGHT VENTRICULAR LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL FOLLOWING LIA (LEAD INTEGRITY ALERT). SHORT V-V INTERVALS, WHICH COULD INDICATE OVERSENSING, WERE NOTED. A POSSIBLE REVISION OF THE LEAD WAS NOTED. 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 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB