BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2813463 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16528
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    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 Location
    GM
    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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS SUMMARY: (B)(4) PERFORMANCE DATA RECEIVED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT A RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED FOR OVERSENSING. THERE WERE ALSO NON-PHYSIOLOGIC / SHORT INTERVAL COUNTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED 31 INAPPROPRIATE SHOCKS DUE TO OVERSENSING AND NOISE ON THE RIGHT VENTRICULAR LEAD. A SUBCLAVIEN LEAD CRUSH WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED 31 INAPPROPRIATE SHOCKS DUE TO OVERSENSING AND NOISE ON THE RIGHT VENTRICULAR LEAD. A SUBCLAVIAN LEAD CRUSH WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB