BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2694332 · Received August 13, 2012

    Report

    Report Number
    2649622-2012-09161
    Event Type
    Injury
    Date Received
    August 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    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) 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. SIXTEEN VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES OF <=210 MS OCCURRED BETWEEN (B)(6) 2008, 12:12:11 AND (B)(6) 2008, 08:41:19. TWO PATIENT ALERTS FOR SVC (HVX) LEAD IMPEDANCE OCCURRED ON (B)(6) 2012, 03:00:03 AND (B)(6) 2012, 03:00:03. DAILY PACE IMPEDANCE LOG DATA SHOWS A SPIKE INCREASE FOR SVC = 50 TO 120 OHMS PEAK BETWEEN (B)(6) 2012 AND (B)(6) 2012, THEN RETURNING TO 62 OHMS ON (B)(6) 2012. TWO PATIENT ALERTS FOR HVB-HVA LEAD IMPEDANCE OCCURRED ON (B)(6) 2012, 03:00:03 AND (B)(6) 2012, 03:00:03. DAILY PACE IMPEDANCE LOG DATA SHOWS A SPIKE INCREASE FOR HVB = 39 TO 126 OHMS PEAK BETWEEN (B)(6) 2012, THEN RETURNING TO 50 OHMS ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT TRIGGERED FOR HIGH IMPEDANCE ON THE HIGH VOLTAGE PORTION OF THE RIGHT VENTRICULAR LEAD. IT WAS DECIDED THAT FOR MEDICAL REASONS THE SYSTEM WOULD BE DOWNGRADED TO A PACING SYSTEM AND THE HIGH VOLTAGE LEAD IS NO LONGER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB