BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2811399 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16608
    Event Type
    Injury
    Date Received
    October 31, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE DISTAL ELECTRODE WAS COVERED IN BLOOD ALONG WITH BODY TISSUE/FIBROTIC GROWTH. THERE WAS A COSMETIC DEPRESSION IN THE OUTER INSULATION. IT WAS ALSO NOTED THERE WAS SUBSTANTIAL TISSUE IN-GROWTH ON THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. DEVICE INTERROGATION REVEALED DECREASED R WAVES AND T WAVE OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE SENSITIVITY WAS REPROGRAMMED. THE PATIENT RETURNED TO THE CLINIC AT A LATER DATE WITH THE SAME ISSUES. THE PHYSICIAN THEN REMOVED THE LEAD AND IMPLANTED A NEW LEAD. 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB