BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1926246 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14251
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 FOR ANALYSIS. PRIMARY ANALYSIS FOUND NO ANOMALIES. ADDITIONALLY, BLOOD/BODY FLUID WERE PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). (B)(4) THE FULL LEAD WAS RETURNED FOR ANALYSIS. PRIMARY ANALYSIS FOUND NO ANOMALIES. ADDITIONALLY, BLOOD/BODY FLUID WERE PRESENT ON THE DISTAL CONDUCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT BOTH THE 4193 AND 4194 LEADS HAD APPARENT FRACTURES. THE LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 20 YR Other