BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1922489 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12965
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED IN THE MEDIAL SECTION. THE DISTAL CONDUCTOR WAS DISTORTED AND HAD BLOOD/FLUID (NON-OBSTRUCTED). THE OUTER INSULATION HAD COSMETIC METAL INDUCED OXIDATION, ENVIRONMENTAL STRESS CRACKING, A COSMETIC CUT, A BREACHED CUT, AND A COSMETIC DEPRESSION. THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE, HIGH/UNSTABLE/VARIABLE THRESHOLD, AND AN APPARENT LEAD FRACTURE ON THE LEFT VENTRICULAR LEAD. THE LEAD WAS EXTRACTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE THERE WAS DIFFICULTY PLACING THE NEW LEAD DUE TO PATIENT ANATOMY. THE LEAD WAS NOT IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R 6948 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB