BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4162439 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19380
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    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
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEIR HEART RATE HAD DROPPED FROM THE NORMAL RATE OF 70 BEATS PER MINUTE TO 60 BEATS PER MINUTE, AND THEY PASSED OUT. INFORMATION FROM THE CLINIC INDICATES THE PATIENT HAS NOT BEEN SEEN IN TWO YEARS. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639698 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRS1

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Life Threatening 5076-52 LEAD, 5076-45 LEAD