BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4161790 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19007
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 24, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE BATTERY MEASUREMENT WAS NOT AVAILABLE. FALSE ERI AND BATTERY VOLTAGE NOT AVAILABLE DUE TO MEASUREMENT SYSTEM LOCK-UP. RESET OF THE DEVICE BY PROGRAMMER WITH UPDATED SOFTWARE CLEARED THE LOCK-UP CONDITION. CONCOMITANT PRODUCT: 4525-53, LEAD, (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PALPITATIONS AND PACEMAKER SYNDROME. THE DEVICE WAS FOUND IN VVI 65 MODE AND UPON INTERROGATION THE BATTERY VOLTAGE WAS NOT AVAILABLE. THE DEVICE WAS REPROGRAMMED BACK TO DUAL CHAMBER MODE 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
    639558 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention 4024-58 LEAD