BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1925745 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14033
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD IMPEDANCE RECORDED BELOW 200 OHMS, THEN ROSE TO 800 OHMS DURING REGULAR CHECKUP. THE PATIENT FELL SERIOUSLY IN (B)(6), AND THE DOCTOR IS GUESSING THAT IT MIGHT HAVE CAUSED DAMAGE TO THE LEAD. THE LEAD PERFORMANCE TREND REPORT SHOWS THAT THIS INSTABILITY STARTED IN (B)(6) 2010. OPERATION FOR NEW ATRIAL LEAD IMPLANT IS SCHEDULED ON (B)(6). 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 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention P1501DR IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD