BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 4832734 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11301
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 2, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCT: 5076-58 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD UNDERSENSING OF ATRIAL FIBRILLATION WITH AN ATYPICAL NOISY ELECTROCARDIOGRAM (EGM). IT WAS ALSO REPORTED THAT THE LEAD THRESHOLDS WERE PROGRAMMED AT 6 VOLTS AT 1.5 MILLISECONDS RESULTING IN THE PACEMAKER TO HAVE PREMATURE BATTERY DEPLETION. THE ATRIAL LEAD WAS CAPPED AND THE PACEMAKER WAS EXPLANTED AND REPLACED WITH A SINGLE CHAMBER PACEMAKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378344 ENRHYTHM DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 5076-52 LEAD