BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1922245 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12825
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 20, 2010
    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
    AU
    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 MELTED. THE DISTAL CONDUCTOR WAS STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND A COSMETIC DEPRESSION. THE LEAD WAS STRETCHED AND APPARENT EXPLANT DAMAGED WAS NOTED. (B)(4): THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THE DEFIB CONDUCTOR WAS DISTORTED. THERE WAS BLOOD/BODY FLUID IN/IN THE DISTAL CONDUCTOR AND OUTER TUBING OVERLAY. THE OUTER TUBING OVERLAY WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKS. APPARENT EXPLANT DAMAGE.

    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, ANALYZED, AND IT WAS OBSERVED THAT THE DISTAL CONDUCTOR WAS MELTED. ADDITIONALLY THE DISTAL CONDUCTOR WAS STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AT VARIOUS LOCATIONS THOUGHOUT THE LEAD, AND A COSMETIC DEPRESSION NEAR THE CONNECTOR. ADDITIONALLY THE LEAD WAS STRETCHED AND APPARENT EXPLANT DAMAGED WAS NOTED. ANALYSIS OF THE OTHER DEVICE 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) THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS MELTED. THE DISTAL CONDUCTOR WAS STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND A COSMETIC DEPRESSION. THE LEAD WAS STRETCHED AND APPARENT EXPLANT DAMAGED WAS NOTED. (B)(4): THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THE DEFIB CONDUCTOR WAS DISTORTED. THERE WAS BLOOD/BODY FLUID IN/IN THE DISTAL CONDUCTOR AND OUTER TUBING OVERLAY. THE OUTER TUBING OVERLAY WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKS. APPARENT EXPLANT DAMAGE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT BETWEEN (B)(6) 2010 THERE WERE FIVE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE. BETWEEN (B)(6) 2010 THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN INCREASE FOR MIN AND MAX RV PACE= 832 TO 5696 OHMS PEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD WAS HIGH AND THE THRESHOLDS HAD INCREASED. UPON EXPLANT AND REPLACMENT OF THE RV LEAD, THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE WAS FOUND TO BE HIGH AS WELL, AND THE LEAD NO LONGER HAD CAPTURE. WHILE EXPLANTING AND REPLACING THE LV LEAD, THE ATRIAL LEAD WAS DESTROYED AND REQUIRED REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WAS HIGH AND THE THRESHOLDS HAD INCREASED. UPON EXPLANT AND REPLACMENT OF THE RV LEAD THE LEFT VENTRICULAR LEAD IMPEDANCE WAS FOUND TO BE HIGH AS WELL, AND THE LEAD NO LONGER HAD CAPTURE. WHILE EXPLANTING AND REPLACING THE LV LEAD, THE ATRIAL LEAD WAS DESTROYED AND REQUIRED REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WAS HIGH AND THE THRESHOLDS HAD INCREASED. UPON EXPLANT AND REPLACMENT OF THE RV LEAD THE LEFT VENTRICULAR LEAD IMPEDANCE WAS FOUND TO BE HIGH AS WELL, AND THE LEAD NO LONGER HAD CAPTURE. WHILE EXPLANTING AND REPLACING THE LV LEAD, THE ATRIAL LEAD WAS DESTROYED AND REQUIRED REPLACEMENT. 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 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB