BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANT S+ VDD

    MDR report key: 1792510 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07132
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    April 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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) NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. THE LEAD WAS RECEIVED WITH THE STYLET STILL IN THE LEAD. AFTER REMOVING THE STYLET A KINK WAS OBSERVED ON THE STYLET. IT CAN'T BE DETERMINED WHEN THIS OCCURRED OR IF THAT IS WHY THE LEAD GOT STUCK IN THE 9FR INTRODUCER SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATTEMPT TO IMPLANT THE VDD PACING THROUGH A 9FR INTRODUCER, AS LABELED. THE LEAD GOT STUCK IN THE INTRODUCER. WHEN IT WAS PULLED BACK OUT OF THE INTRODUCER, THE PHYSICIAN SAW A KINK IN THE DISTAL TIP. THE LEAD WAS RETURNED. ADDITIONAL COMMUNICATION FROM THE CUSTOMER CLARIFIED THAT THE ISSUE WAS NOT WITH THE VDD PACING LEAD, BUT RATHER THE 9 FR INTRODUCER WHICH REPORTEDLY "KINKED" INSIDE THE VEIN AND WOULD NOT ALLOW THE VDD LEAD TO PASS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.;

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATTEMPT TO IMPLANT THE VDD PACING THROUGH A 9FR INTRODUCER, AS LABELED. THE LEAD GOT STUCK IN THE INTRODUCER. WHEN IT WAS PULLED BACK OUT OF THE INTRODUCER, THE PHYSICIAN SAW A KINK IN THE DISTAL TIP. THE LEAD WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANT S+ VDD IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMW15Q ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R