BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1802755 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08697
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 23, 2010
    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
    OR, 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) NO ANOMALIES FOUND; BLOOD OBSERVED ON ALL CONDUCTORS; FULL LEAD ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD HAD HIGH THRESHOLD. THE PACE/SENSE FUNCTION OF THE RV HIGH VOLTAGE LEAD WAS REPLACED WITH A PACE/SENSE LEAD. THERE WAS MUSCLE/NERVE STIMULATION DUE TO THE 4194 LV LEAD. DURING IMPLANT ATTEMPT FOR A NEW 4196 LV LEAD, THERE WAS POSITIONING/FIXATION DIFFICULTY DUE TO PATIENT ANATOMY. THE 4194 LV LEAD IS STILL IN USE. 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 44 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD