BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2203472 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04183
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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 STATED THAT SWELLING IN LEFT ARM AND NECK AREA. THE PATIENT TALKED TO THE HEART MEDICAL DOCTOR AND HAD TOLD THE PATIENT TO TALK TO THE FAMILY MEDICAL DOCTOR. THE PATIENT WENT TO EMERGENCY ROOM LAST NIGHT AND THE NURSE TOLD THE PATIENT "THIS IS FROM THE PACEMAKER". THE PHYSICIAN WAS CONTACTED AND DURING TWO VISITS THE PATIENT DID NOT COMPLAIN OF SWELLING. THE DEVICE WAS NOTED TO BE FUNCTIONING NORMALLY. THE DEVICE IS STILL 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
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other 5076 X2 IMPLANTABLE PACING LEAD