BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2812348 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17427
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, NO ANOMALIES WERE FOUND, THE ANALYST COMMENTED,SPECIFICATION FOR DISTANCE BETWEEN SEALING RINGS AND PIN CAP IS 0.070" MAXIMUM. THE LEAD RETURNED MEASURES 0.056" AND IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE LEAD CONNECTOR WAS LOOSE WHEN DEPLOYING THE HELIX. THERE WAS A TWO TO THREE MILLIMETER IN AND OUT MOVEMENT OF THE PACE/SENSE PIN. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PRODUCT HAS NOW BEEN RETURNED AND ANALYSIS IS IN PROGRESS. UPON COMPLETION OF ANALYSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 Other