BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 3152834 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08849
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO LOW BATTERY VOLTAGE PRIOR TO EXPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PACEMAKER SYNDROME WITH SHORTNESS OF BREATH, DIZZINESS, AND LIGHTHEADEDNESS. THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND WAS IN VVI MODE. THE DEVICE WAS REPROGRAMMED TO DDD AND LATER EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254862 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 X 2 IMPLANTABLE PACING LEADS