BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2203568 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04427
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FEELS AWFUL SINCE THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE CHECK; THEREFORE THE IPG RATE RESPONSE WAS ADJUSTED. HOWEVER, PER THE PATIENT THREE DAYS LATER, "MY HEART WAS FIBRILLATING FOR FIVE DAYS; I WAS EXHAUSTED AND DIDN'T FEEL GOOD." SO, ANOTHER DEVICE ADJUSTMENT WAS COMPLETED RESETTING THE DEVICE BACK TO WHERE IT WAS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ONCE AGAIN SEEN AND IT WAS DETERMINED THAT THE IPG WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI.) THEREFORE THE IPG WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEADS