BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2113072 · Received June 3, 2011

    Report

    Report Number
    2182208-2011-00698
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 5, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR APPEARS ABRADED AT THE FRACTURE LOCATION, THE OUTER INSULATION HAD AN ABRASION (BREACHED), THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    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, ANALYZED AND IT WAS NOTED THAT A RIBBON CABLE WAS BROKEN. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR APPEARS ABRADED AT THE FRACTURE LOCATION, THE OUTER INSULATION HAD AN ABRASION (BREACHED), THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    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, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR APPEARS ABRADED AT THE FRACTURE LOCATION, THE OUTER INSULATION HAD AN ABRASION (BREACHED), THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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, ANALYZED AND IT WAS NOTED THAT A RIBBON CABLE WAS BROKEN. (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR APPEARS ABRADED AT THE FRACTURE LOCATION, THE OUTER INSULATION HAD AN ABRASION (BREACHED), THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    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

    ASKU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DEVICE CHECK AFTER A FALL FROM A BICYCLE. OVERSENSING AND NOISE WERE NOTED ON THE LEADS CONNECTED TO THE RIGHT VENTRICULAR AND LEFT VENTRICULAR PORT (BOTH RIGHT VENTRICULAR LEADS) AND OVERSENSING AND NOISE WERE NOTED DURING LIGHT ABDOMINAL PRESSURE. AFTER DISCONNECT FROM THE DEVICE, BOTH RIGHT VENTRICULAR LEADS HAD NORMAL ELECTROGRAMS AND STABLE IMPEDANCE AND REMAIN IN USE. OVERSENSING AND NOISE WERE SEEN ON THE ATRIAL LEAD, WHICH HAD A CHRONIC UNDEFINED MALFUNCTION AND INSULATION DAMAGE WAS REPORTED WHEN THE LEAD WAS REMOVED AND REPLACED. THE DEVICE WAS ALSO REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R