BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 5859996 · Received August 9, 2016

    Report

    Report Number
    2182208-2016-01942
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    April 27, 2016
    Report Date
    June 13, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE. THE BASELINE GENDER/AGE CHARACTERISTICS OF THE PATIENTS REFERENCED IN THE ARTICLE IS MALE/(B)(6) YEARS OLD. 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: PECHA S, KENNERGREN C, YILDIRIM Y, GOSAU N, AYDIN A, WILLEMS S, ET AL. (2016) CORONARY SINUS LEAD REMOVAL: A COMPARISON BETWEEN ACTIVE AND PASSIVE FIXATION LEADS. PLOS ONE 11(4): E0153651. DOI:10.1371/JOURNAL.PONE.0153651.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING CORONARY SINUS LEADS AND THEIR REMOVAL. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THE LEADS WERE REMOVED DUE TO INFECTION AND/OR SEPSIS. THERE WERE ALSO REPORTS OF ¿PARTIAL RETRACTION OF THE PROXIMAL LOBES,¿ ¿AN ABANDONED LEAD FRAGMENT AFTER THE EXTRACTION FAILURE,¿ AS WELL AS OTHER UNSPECIFIED ¿LEAD EXTRACTION FAILURES,¿ AN APPARENT LEAD FRACTURE DURING REMOVAL, AND THERE WERE REPORTS OF FIBROTIC TISSUE GROWTH BETWEEN THE FIXATION LOBES. THE STATUS OF THE LEADS IS UNKNOWN. OF NOTE, THE AUTHOR INDICATED THAT THERE WERE NO PROCEDURAL COMPLICATIONS AS A RESULT OF THE LEAD EXTRACTION DURING THE 30-DAY FOLLOW UP PERIOD. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510104 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC, INC. 4296

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention