BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 4973561 · Received August 5, 2015

    Report

    Report Number
    3004209178-2015-15383
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 DEVICES: 5076-45 LEAD, IMPLANTED: (B)(6) 2015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN AVJ (ATRIOVENTRICULAR JUNCTION) ABLATION ONE WEEK POST-IMPLANT, WITH THE LOWER RATE BEING SET TO 80 BPM. ABOUT FOUR MONTHS LATER, THE PHYSICIAN LOWERED THE LOWER RATE TO 60 BPM. SHORTLY THEREAFTER, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE, WITH THE PATIENT PASSING OUT AND HITTING THEIR HEAD, WHEREUPON THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM. NO EVIDENCE OF HIGH VENTRICULAR RATES WAS NOTED, BUT THERE WAS AN AT/AF (ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION) EPISODE IN PROGRESS. THE DEVICE REMAINS 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
    513623 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Life Threatening 5076-52 LEAD