BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990745 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08507
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    January 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE LEAD AND HAVE ANALYZED THE DATA. THE ATRIAL PACING IMPEDANCE TREND STEADILY ROSE TO A HIGH OF 1311 OHMS BEGINNING THE WEEK OF 2014-(B)(6). THE ATRIAL PACING IMPEDANCE WAS TRENDING AT 513 OHMS AND SPIKED TO 1064 OHMS. JUST WEEKS AFTER IMPLANT, ATRIAL CAPTURE THRESHOLD ROSE TO GREATER THAN 2.5 VOLTS AND REMAINED ELEVATED. CANNOT CONFIRM ATRIAL UNDERSENSING OR ATRIAL LOSS OF CAPTURE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 6947 LEAD, IMPLANTED (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS UNABLE TO CAPTURE AT MAXIMUM OUTPUT AND HAD A RISE IN THRESHOLD ABOUT FOUR WEEKS AFTER IMPLANT. THE LEAD ALSO HAD A GRADUAL RISE IN IMPEDANCE AND IS NOW HIGH AND IS UNDERSENSING. THE LEAD HAD DISLODGED. DURING THE LEAD REVISION PROCEDURE, AFTER VIEWING THE FLUOROSCOPY, THE PHYSICIAN FELT THERE MAY HAVE BEEN A POSSIBLE PERFORATION. WHEN ATTEMPTING TO RETRACT THE HELIX, IT WOULD NOT RETRACT IMMEDIATELY. THE PHYSICIAN CHOSE NOT TO ATTEMPT FURTHER ROTATIONS AND 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
    467312 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| L| R DDBB1D4 ICD