BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STABILITY

    MDR report key: 4834228 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01936
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 1, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP WITH THE AUTHOR WHO HAS PROVIDED THE INFORMATION IN THIS EVENT FILE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: EARLY EXPERIENCE WITH ATTAIN STABILITY, AN ACTIVE FIXATION LV LEAD: VIRTUES AND PITFALLS. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2015;38(3):297-301.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: ¿EARLY EXPERIENCE WITH ATTAIN STABILITY, AN ACTIVE FIXATION LV LEAD: VIRTUES AND PITFALLS.¿ PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2015;38(3):297-301. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT'S (CASE 5) LEFT VENTRICULAR (LV) LEAD. THE ARTICLE REFERENCES THAT THE LV LEAD WAS DIFFICULT TO FIX DUE TO A LARGE VEIN; AND SUBSEQUENTLY A DIFFERENT STYLUS WAS USED TO FIX THE LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT'S (CASE 5) LEFT VENTRICULAR (LV) LEAD. THE ARTICLE REFERENCES THAT THE LV LEAD WAS DIFFICULT TO FIX DUE TO A LARGE VEIN; AND SUBSEQUENTLY A DIFFERENT STYLUS WAS USED TO FIX THE LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.ON 2015-07-21 ADDITIONAL INFORMATION WAS RECEIVED THROUGH FOLLOW UP WITH THE AUTHOR WHO INDICATED THAT THERE WERE NO ISSUES WITH THE LEAD AND NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374710 ATTAIN STABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC, INC. 20066

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ICD