BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA VR

    MDR report key: 1922504 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02209
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 27, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEVICE WAS RETURNED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED. THE OUTER INSULATION HAD CUTS, WHERE SOME BREACHED AND SOME WERE COSMETIC. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND ON THE SLEEVEHEAD. THERE WAS A TIP SEAL OBSERVATION AND APPARENT EXPLANT DAMAGE. THE ANALYST NOTED THAT THERE IS ONLY SET OF SETSCREW MARKS ON THE IS-1 PIN AND IT IS TOO PROXIMAL; THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE.

    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 IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE SHOCK DUE TO NOISE. THE PHYSICIAN SUSPECTED THAT THE SET SCREW WAS LOOSE BASED ON X-RAY. THE LOOSE CONNECTION WAS NOT CONFIRMED. THE DEFIBRILLATION LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D234VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R