BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2203579 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04428
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE PATIENT CALLED TO SEE IF THEIR IMPLANTABLE PULSE GENERATOR (IPG) DEVICE IS PROGRAMMED TO PACE WHEN EXERCISING. PATIENT STATED "I FEEL FINE, BUT IF I GET UP TO DO SOMETHING, I BEGIN TO GET THIS PRESSURE IN MY THROAT; IF I GO FOR A WALK, I GO 25-30 FEET, AND I GET THE PRESSURE. I GET OUT OF BREATH FROM IT." FOLLOW UP DID NOT YIELD ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE COMPLAINT; HOWEVER THE IPG RATE RESPONSE WAS TURNED OFF. THE DEVICE IS FUNCTIONING APPROPRIATELY AND 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
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention 5592 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD