BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE ACTIVE FIXATION

    MDR report key: 3861822 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01743
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. CORRESPONDENCE WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AT THE TIME OF THIS REPORT. 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: CLOSE PROXIMITY OF LEFT ANTERIOR DESCENDING ARTERY TO THE RIGHT VENTRICULAR LEAD APPARENTLY IMPLANTED INTO THE MID-SEPTUM. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. 2014;14(2):83-86. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS RIGHT VENTRICULAR (RV) LEAD. IT WAS DISCOVERED THAT AT THE SIX-WEEK FOLLOW-UP APPOINTMENT, THE LEAD HAD RELOCATED AND WAS ¿ALMOST TOUCHING THE LAD [LEFT ANTERIOR DESCENDING ARTERY].¿ THE STATUS OF THE LEAD IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339712 CRYSTALLINE ACTIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. ICQ09B

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R