BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1924476 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13573
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 7, 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
    NY, 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 WERE FOUND; THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED). (B)(4) NO ANOMALIES WERE FOUND; THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS FOUND ON ALL CONDUCTORS (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DIFFERENT LEFT VENTRICULAR LEAD IMPLANTS WERE ATTEMPTED, BUT HIGH THRESHOLDS AND PHRENIC NERVE STIMULATION OCCURRED. THE LEADS WERE 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 79 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD