BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1924330 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13518
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEADS WERE NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE. ANALYSIS INDICATED HIGH RESISTANCE/IMPEDANCE PACING ON BOTH THE ATRIAL AND VENTRICULAR LEADS. THE 946 HIGH IMPEDANCE PACES RECORDED ON THE VENTRICULAR LEAD POST LEAD-WARNING ON (B)(4) 2010. 1,541 HIGH IMPEDANCE PACES RECORDED ON THE ATRIAL LEAD POST LEAD WARNING ON (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE ATIAL AND VENTRICULAR LEADS HAD HIGH IMPEDANCE, LEAD WARNINGS HAD OCCURRED, AND THAT THE VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE PATIENT HAD A LEAD REVISION. IT WAS LATER REPORTED THAT THERE WAS A SUBSEQUENT REVISION ON THE VENTRICULAR LEAD. BOTH LEADS REMAIN IN USE. 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 90 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR