BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1926179 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14212
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 13, 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
    MO, 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; FULL LEAD ANALYZED. BLOOD PRESENT IN/ON THE LOBE MECHANISM. (B)(4) NO ANOMALIES FOUND; FULL LEAD ANALYZED. BLOOD/BODY FLUID PRESENT ON ALL CONDUCTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE ATTAIN ABILITY LEAD WAS DIFFICULT TO POSITION AND CAUSED DIAPHRAGMATIC STIMULATION. IT WAS ALSO REPORTED THAT THE ATTAIN STARFIX LEAD WAS DIFFICULT TO POSITION. BOTH LEADS WERE REMOVED AND REPLACED. NO 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 79 YR Other 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR