BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4163041 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19299
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 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
    NY, 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: 407652 LEAD IMPLANTED: 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CALLED AND STATED THAT EVERY NIGHT SHE EXPERIENCES A SENSATION IN HER CHEST AND OCCASIONALLY WILL GET LIGHTHEADED. THE PATIENT STATED THAT THIS HAS BECOME MORE FREQUENT. FOLLOW-UP WAS CONDUCTED WITH THE CLINIC AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT HAS BEEN SEEN IN THE CLINIC AND THAT THEIR DEVICE WAS REPROGRAMMED FROM SIXTY TO FIFTY. IT WAS NOTED THAT THE PATIENT HAS PALPITATIONS AND HAS BEEN PRESCRIBED MEDICATIONS FOR THAT. THE PATIENT IS TO BE SEEN AGAIN IN SEPTEMBER. 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
    639074 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention 457445 LEAD