BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3860949 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11066
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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. CONCOMITANT MEDICAL PRODUCTS: 4076-52 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED WITH NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP OF THE IMPLANTABLE PULSE GENERATOR (IPG), THE PROGRAMMER DISPLAYED AN INVALID DATA MESSAGE AND THE ATRIAL ELECTROGRAMS (EGMS) AND OTHER DATA COULD NOT BE VIEWED. STORED DEVICE DATA REVEALED THAT A LONGER DURATION MODE SWITCH HAD PREVIOUSLY OCCURED WHICH MAY HAVE RESULTED IN THE PERIOD OF INVALID DATA COLLECTION. POTENTIAL FAR-FIELD R-WAVE OVERSENSING WAS SUSPECTED. THE DEVICE 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
    342175 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR 4076-58 IMPLANTABLE PACING LEAD