BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 2952357 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01705
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT: 5076 NON-DEFIB LEAD; (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT "THEY CAN FEEL A TAPPING INSIDE, LIKE AN ELECTRICAL JOLT AT TIMES" AND WANTED TO KNOW WHY THIS HAPPENED. THE PHYSICIAN CHECKED THE DEVICE AND DIDN'T KNOW WHY THIS HAPPENED BUT REPROGRAMMED SOME SETTINGS. THE PHYSICIAN INFORMED THE PATIENT THAT SOME PATIENTS ARE MORE SENSITIVE AND CAN FEEL WHEN THEIR DEVICE STARTS PACING THE HEART. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55578 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 NON-DEFIB LEAD