BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1874592 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11456
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 16, 2010
    Report Date
    February 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. CORRECTED OTHER DEVICES. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(6)2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.17 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.85 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERROGATED BATTERY VOLTAGE WAS 2.17 V, BUT REVIEW OF DEVICE DATA SHOWED AN AVERAGE BATTERY VOLTAGE OVER THE LAST 14 DAYS OF 2.85 V. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD CHRONIC HIGH THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD