BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2131958 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00931
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 1, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THIS EVENT OCCURRED OUTSIDE THE U.S. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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: "REPOSITION OF CORONARY SINUS LEAD DISLOCATION ONLY USING PRE-SHAPED STYLET AND GUIDEWIRE: A CASE REPORT." CHIN. MED. J. MARCH 1 2011;124(6):954-955.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. IT WAS REPORTED THAT THREE MONTHS AFTER IMPLANTATION, THE LEAD HAD DISLOCATED. THE ARTICLE REPORTS THAT THIS WAS RESOLVED WITH REPOSITIONING. IT APPEARS THE LEAD REMAINS IN USE. FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. 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 OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R INSYNC III IMPLANTABLE PACEMAKER/CARDIO/DEFIB