BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 4833885 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11160
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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, 5076-52 CRDM NON-DEFIB LEAD IMPLANTED: (B)(6) 2015. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER ATTACHING THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS TO THE DEVICE, THE PHYSICIAN WANTED TO TIGHTEN THE RA LEAD SOME MORE. HE WAS UNABLE TO TIGHTEN THE SCREW OR LOOSEN THE SET SCREW AND HE COULD NOT REMOVE THE RA LEAD FROM THE DEVICE. THE PHYSICIAN REMOVED THE GROMMET TO GET A CLOSER LOOK AT THE SET SCREW AND DETERMINED THAT THE SET SCREW WAS STRIPPED. HE SAID IT JUST KEEPS TURNING WITHOUT TURNING THE SCREW. THE DEVICE WAS INTERROGATED AND RA LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PHYSICIAN COVERED THE SET SCREW WITH ADHESIVE. THE DEVICE AND LEADS REMAIN 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
    376013 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. A2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR