BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2812768 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16469
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND, HOWEVER THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND WAS MELTED, THERE WAS BLOOD ON THE PROXIMAL AND DISTAL CONDUCTORS, AND THERE WAS APPARENT EXPLANT DAMAGE; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE LEAD WAS EXPLANTED AND REPLACED. 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 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC PUERTO RICO, INC. 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD