BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2813034 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16234
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED), WAS PULLED/STRETCHED, FRACTURED DUE TO BEING STRETCHED/OVERSTRESSED AND WAS KINKED/BUCKLED. ALSO, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, BREACHED/TORN, CUT AND HAD COSMETIC MELTING. THE LEAD HAD APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THE LEAD WAS UNSUCCESSFULLY ATTEMPTED TO BE REVISED. THE LV LEAD REMAINED IN USE UNTIL IT WAS LATER EXPLANTED AND REPLACED. NO 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 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTB MEDTRONIC PUERTO RICO, INC. 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB