BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 2053519 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01629
    Event Type
    Malfunction
    Date Received
    April 13, 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 FELT GREAT AFTER THE IMPLANT BUT NOW FEELING VERY TIRED, NOT WELL. PATIENT WAS WONDERING IT HAS TO DO WITH CIRCUIT BOARDS FROM THE WORK PLACE. THE TECHNICAL SERVICE REFERRED PATIENT TO CONTACT THE CURRENT PHYSICIAN. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING ATRIAL FIBRILLATION AND HAD A CARDIOVERSION. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT GREAT AFTER THE IMPLANT BUT NOW FEELING VERY TIRED, NOT WELL. PATIENT WAS WONDERING IT HAS TO DO WITH CIRCUIT BOARDS FROM THE WORK PLACE. THE TECHNICAL SERVICE REFERRED PATIENT TO CONTACT THE CURRENT PHYSICIAN. 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
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 4076 (X2) IMPLANTABLE PACING LEAD| 4076 (X2) IMPLANTABLE PACING LEAD