BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 1875030 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11616
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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): NO ANOMALIES FOUND, PROXIMAL SEGMENT. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE ATRIAL LEAD IMPEDANCE MEASUREMENT HAS BEEN VARIABLE AND TRENDING LOWER OVER THE DURATION OF THE RECORD. THE MIN RANGE HAS BEEN 90 - 216 OHMS AND THE MAX RANGE HAS BEEN 160 - 328 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD CONCERN REGARDING THE ATRIAL LEAD INTEGRITY. REVIEW OF THE DEVICE DATA SHOWED THAT THE ATRIAL LEAD HAD BEEN DETERIORATING FOR A LONG TIME, WITH LOW IMPEDANCE LESS THAN 200 OHMS FOR THE LAST 80 WEEKS. THE LEAD WAS REMOVED 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 4068 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| P1501DR IMPLANTABLE PULSE GENERATOR