BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3051027 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01022
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 8, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT AND LEFT VENTRICULAR LEADS WERE DISLODGED ONE DAY POST IMPLANT. FOLLOW UP WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION REGARDING THE MODEL, SERIAL NUMBERS, OR CLARIFICATION REGARDING THE INTERVENTION TAKEN. THE LEADS WERE SURGICALLY REPLACED OR REPOSITIONED. THE PATIENT WAS REPORTED TO BE ENROLLED IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149511 UNKNOWN ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DTBA2D4 BI-VENTRICULAR DEFIBRILLATOR