BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1924061 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13364
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    March 24, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND; FULL LEAD ANALYZED. BLOOD/BODY FLUID PRESENT ON ALL CONDUCTORS. (B)(4) NO ANOMALIES FOUND; FULL LEAD ANALYZED. LEAD STRETCHED; LEAD DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTAIN OTW LEAD WAS CONTAMINATED AND THE ATTAIN ABILITY LEAD WAS UNABLE TO BE POSITIONED. BOTH LEADS WERE NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other