BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 2130148 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10120
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION HAD FOREIGN MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE LEAD HAD A FLUID FILLED BLADDER UNDER THE SILICONE INSULATION OF THE LEAD, CLOSE TO THE CONNECTOR PIN. THE EXACT ORIGIN WAS UNKNOWN. THE EVENT OCCURRED AFTER ADMINISTRATION OF NITROGLYCERIN. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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 ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other