BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1921528 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12575
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) OUTER INSULATION BREACHED EVIRONMENTAL STRESS CRACKING (ESC). THE FULL LEAD WAS RETURNED AND ANALYZED. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION MELTED, OUTER INSULATION COSMETIC ESC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INFECTION, INCLUDING POCKET EROSION. THE LEAD WAS REMOVED. 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. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5592 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD