BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3992171 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14895
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 13, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    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: 5086MRI45; LEAD, IMPLANTED: (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST-IMPLANT, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD HAD BECOME DISLODGED AND EXPERIENCED NON-CAPTURE. THE LEADS WERE REVISED, HOWEVER THE RA LEAD DISLODGED AGAIN AND THE RV LEAD EXHIBITED INCREASED THRESHOLD AND INTERMITTENT LOSS OF CAPTURE FOLLOWING THE REVISION. THE PHYSICIAN UNSCREWED AND SCREWED IN THE SETSCREW OF THE DEVICE TO DETERMINE IF THAT WAS THE ISSUE. THE PHYSICIAN FINALLY ELECTED TO EXPLANT AND REPLACE BOTH LEADS. UPON CONNECTION OF THE NEW LEADS, THE DEVICE EXPERIENCED INTERMITTENT LOSS OF CAPTURE. THE LEADS WERE CONNECTED TO THE ANALYZER WITH STABLE THRESHOLDS AND IMPEDANCES NOTED. THE PHYSICIAN ATTEMPTED THIS THREE TIMES WITH INTERMITTENT LOSS OF CAPTURE NOTED EACH TIME. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE AND SET THE DEVICE TO DOO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470515 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 5086MRI52 LEAD