BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810805 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16308
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 22, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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) THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS DISTORTED, AND THE NUMBER OF TURNS REQUIRED TO EXTEND/RETRACT THE HELIX EXCEEDS SPECIFICATIONS. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM, AND TISSUE WAS FOUND ON THE HELIX. THE LEAD EXHIBITED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE MONTHS OF IMPLANT, THE LEAD WAS DETERMINED TO BE KINKED. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, BUT THE HELIX WOULD NO LONGER EXTEND. THE LEAD WAS EXPLANTED AND REPLACED. 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 IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R