BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1992168 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-03002
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    April 14, 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
    GA, 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, HOWEVER BLOOD WAS NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED); THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE DOCTOR WAS UNABLE TO GET ADEQUATE PACING AND SENSING THRESHOLDS WITHOUT DIAPHRAGMATIC STIMULATION DUE TO PATIENT ANATOMY. THE LEAD WAS NOT USED. IT WAS FURTHER REPORTED THAT THERE WAS A LEAD DISLODGEMENT. THE LEAD WAS EXPLANTED AND REPLACED. 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 87 YR Hospitalization| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD