BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1874559 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11441
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    November 1, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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

    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 OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKING (ESC) BREACH (NON-ELECTRICAL); DEFIB CONDUCTOR DISTORTED; DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED); BLOOD/BODY FLUID ON OUTER TUBING OVERLAY; OUTER TUBING OVERLAY MELTED; OUTER INSULATION COSMETIC ESC.

    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 RV LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. CORRECTED ADVERSE EVENT.

    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 OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKING (ESC) BREACH (NON-ELECTRICAL); DEFIB CONDUCTOR DISTORTED; DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED); BLOOD/BODY FLUID ON OUTER TUBING OVERLAY; OUTER TUBING OVERALY MELTED; OUTER INSULATION COSMETIC ESC; THE INNER TUBING WAS KINKED/BUCKLED AND THE OUTER TUBING OVERLAY WAS BREACHED CUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT VENTRICULAR LEAD DISLODGMENT AND THAT THE RIGHT VENTRICULAR LEAD HAD AN INSULATION BREAK ON THE DISTAL PORTION OF THE LEAD. THE LEADS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW ASKU DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| LEAD/STJ IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB