BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203341 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12107
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FOR (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WAS A MEASUREMENT SYSTEM LOCK-UP ISSUE. THE DEVICE HAD UNCLEARABLE ERI.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE INTERROGATION SHOWED ELECTIVE REPLACEMENT INDICATOR (ERI), BUT THERE WERE NO BATTERY MEASUREMENTS. SOFTWARE WAS DOWNLOADED AND THE DEVICE WAS REPROGRAMMED TO CLEAR THE FALSE ERI. THE BATTERY STATUS WAS ACCEPTABLE AND THE DEVICE REMAINS IN USE. IT WAS ALSO NOTED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION AND BOTH THE ATRIAL AND VENTRICULAR LEADS HAD SHOWN LOW IMPEDANCE. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE INTERROGATION SHOWED ELECTIVE REPLACEMENT INDICATOR (ERI), BUT THERE WERE NO BATTERY MEASUREMENTS. SOFTWARE WAS DOWNLOADED AND THE DEVICE WAS REPROGRAMMED TO CLEAR THE FALSE ERI. THE BATTERY STATUS WAS ACCEPTABLE AND THE DEVICE REMAINS IN USE. IT WAS ALSO NOTED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION AND BOTH THE ATRIAL AND VENTRICULAR LEADS HAD SHOWN LOW IMPEDANCE. BOTH LEADS REMAIN IN USE. IT WAS FURTHER REPORTED THAT THERE WERE NO LEAD IMPEDANCE READINGS ON THE REMOTE TRANSMISSION AFTER RESET OF THE DEVICE, AND THE IMPEDANCE READINGS FOR BOTH LEADS THE WEEK OF THE FALSE ERI WERE "STRANGE" (LESS THAN 100). IN ADDITION, CHRONIC LEAD TREND WAS PROGRAMMED OFF. IT WAS CONFIRMED THAT IT IS POSSIBLE TO GET INVALID IMPEDANCE READINGS JUST PRIOR TO FALSE ERI, AND CHRONIC LEAD TREND ALSO TURNS OFF. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention