BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153543 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06097
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THERE WAS RIGHT VENTRICULAR (RV) LEAD OVERSENSING WITH 44 VENTRICULAR NON-SUSTAINED TACHYCARDIA¿S LESS THAN EQUAL TO 210 MS BETWEEN (B)(6) 2013. ALSO, THERE WERE EIGHT VENTRICULAR FIBRILLATIONS LESS THAN EQUAL TO 200 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2013. THERE WAS ALSO NON-PHYSIOLOGICAL OVERSENSING WITH VENTRICULAR SHORT INTERVAL COUNT EQUAL TO 999 COUNTS, IN 0.67 DAYS ON BETWEEN (B)(6) 2013. PRODUCT: 7278 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2010; 4076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER RECEIVING 14 INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAD OVERSENSING AND A SUSPECTED FRACTURE. THE RV LEAD REMAINS IMPLANTED BUT IS OUT OF SERVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258345 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| L| R