BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1920812 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12342
    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
    ND, 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. THE INITIAL REPORT OF INFECTION WAS RECEIVED ON 20AUG2010 AND IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORTING (ASR) THAT WOULD HAVE BEEN DUE ON 31JAN2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON 31OCT2010 THAT REVEALED A MALFUNCTION. AS THERE IS NEW INFORMATION, THIS EVENT NO LONGER QUALIFIES FOR ASR, AND IS THEREFORE BEING SUBMITTED AS A BIMONTHLY REPORT. EVALUATION SUMMARY: (B)(4): FULL LEAD WAS RETURNED AND ANALYZED. OUTER INSULATION BREACHED ENVIRONMENTAL STRESS CRACKING (ESC), ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC ESC, OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED DUE TO INFECTION. THE LEAD WAS RETURNED, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATIONS. 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 60 YR Hospitalization| R C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4592 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD