BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3993688 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14597
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 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
    MN, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PROGRAMMED TO A DUAL PACING ONLY MODE DURING A VALVE OPERATION WITH THE USE OF A BOVIE. THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD HAD COMPLETE LOSS OF CAPTURE WHILE IN THIS MODE. IT WAS NOTED THAT THE RA LEAD HAD SWITCHED POLARITY; THE RV LEAD AND THE IPG WAS GETTING INTERFERENCE FROM THE BOVIE. THE IPG WAS THEN REPROGRAMMED TO A DUAL SENSING ONLY MODE WITH THE PATIENT BEING PACED EXTERNALLY WITH EPICARDIAL LEADS. AFTER THE VALVE OPERATION, THE IPG WAS REPROGRAMMED BACK TO NORMAL USE. THE IPG AND LEADS WERE TESTED TO BE WORKING AS NORMAL WITH NO PERFORMANCE ISSUE. THE IPG AND LEADS REMAIN 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
    468530 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 4074-52 LEAD, 4574-45 LEAD