BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1922476 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12957
    Event Type
    Injury
    Date Received
    December 13, 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
    OH, 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 AND ANALYZED. ANALYSIS RESULTS REVEALED THERE WERE NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR. ALL CONDUCTORS WERE OBSERVED TO BE DISTORTED. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THERE WERE NO ANOMALIES FOUND. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THERE WERE NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMATIC DIAGHRAGMATIC STIMULATION AND LOSS OF LEFT VENTRICULAR (LV) CAPTURE. THE PATIENT'S DEVICE WAS PROGRAMMED TO DISABLE LV PACING AND THE LEAD WAS REVISED THE FOLLOWING DAY. DURING THE REVISION PROCEDURE, THE DISLODGED LV LEAD WAS REMOVED. THE FIRST ATTEMPTED REPLACEMENT LV LEAD COULD NOT BE PLACED BECAUSE THE TARGET VEIN WAS TOO SMALL AND TORTUROUS FOR THE LEAD. THE SECOND ATTEMPTED REPLACEMENT LV LEAD COULD NOT BE PLACED IN THE TARGET BRANCH BECAUSE OF A SPASM/OCCLUSION. NEITHER OF THE TWO REPLACEMENT LEADS WERE USED. A THIRD REPLACEMENT LV LEAD WAS SUCCESSFULLY PLACED. NO FURTHER 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 57 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR