BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT SECURE

    MDR report key: 1992511 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02892
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. ANALYSIS OF THE LEAD AND SLITTER IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): OUTER INSULATION BREACHED CUT, THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THE LEAD APPEARED DAMAGE AT IMPLANT AND THE LEAD WAS STRETCHED; FULL LEAD RETURNED AND ANALYZED. SLITTER: NO ANOMALIES FOUND, HOWEVER SLITTER DAMAGED AT IMPLANT; THE ANALYST NOTED THAT THE SLITTER BLADE WAS DAMAGED, BENT, AND DULL. THE NOSE OF SLITTER WAS SCRATCHED UP, WITH POSSIBLE SIGNS OF REUSE. CONSIDERABLE BLOOD VISIBLE ON HANDLE.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE HELIX HAD BEEN POSITIONED IN THE RIGHT VENTRICLE, THE LEAD WAS DAMAGED DURING SLITTING OF THE OUTER CATHETER. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT SECURE IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 3830 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other