BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1922692 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13039
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 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
    NC, 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 FOR ANALYSIS. FURTHER TESTING REVEALED THAT ALL CONDUCTORS HAD BLOOD/BODY FLUID, NOT OBSTRUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT, THE LEFT VENTRICULAR PACING LEAD DID NOT GO OUT AS FAR AS THE DOCTOR WANTED. WHEN CLOSING THE POCKET, THE LEAD DISLODGED. THE LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT THE SCRUB TECHNICIAN NOTED THAT SALINE WAS SPRAYING OUT THE SIDE OF THE LEAD WHEN THE LEAD WAS BEING FLUSHED PRIOR TO RETURNING THE LEAD TO THE MANUFACTURER'S REPRESENTATIVE. 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 51 YR Hospitalization| R 7120 IMPLANTABLE TACHY LEAD