BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 14322980 · Received May 7, 2022

    Report

    Report Number
    2182208-2022-01458
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    January 1, 2021
    Report Date
    May 6, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/(B)(6). THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: LEFT BUNDLE BRANCH PACING OF HIS-PURKINJE CONDUCTION SYSTEM: INITIAL EXPERIENCE. ARQUIVOS BRASILEIROS DE CARDIOLOGIA. 2022; 118(2):505-516. DOI: HTTPS://DOI.ORG/10.36660/ABC.20201085. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING LEFT BUNDLE BRANCH PACING OF HIS-PURKINJE CONDUCTION SYSTEM. THE ARTICLE REPORTS ONE PATIENT WHO PRESENTED WITH A PAROTID ABSCESS, BACTEREMIA AND POSITIVE BLOOD CULTURES TWO WEEKS POST IMPLANT. THE PATIENT CHOSE NOT TO REMOVE THE ELECTRODES AND THE IMPLANTABLE PULSE GENERATOR (IPG). THEY WERE TREATED WITH A CONTINUOUS USE OF ANTIBIOTICS. AFTER SEVEN MONTHS OF ORAL MEDICATION, THE PATIENT PRESENTED WITH SIGNS OF INFECTION. THE IPG AND LEADS WERE REMOVED, AND A NEW PACEMAKER IMPLANT OCCURRED AFTER THE INFECTION WAS CONTROLLED. THERE WAS ALSO A LEAD IMPLANT ATTEMPT WHERE THE SHEATH WAS DIFFICULT TO HANDLE AND PREVENTED MAPPING OF THE HIS AXIS. AFTER SEVERAL ATTEMPTS, TWO SHEATHS FRACTURED WHICH PROLONGED THE PROCEDURE. A DIFFERENT LOCATION WAS USED FOR THE IMPLANT. ONE OTHER PATIENT PRESENTED APPROXIMATELY 30 DAYS POST IMPLANT AND A THORACIC X-RAY CONFIRMED A DISLODGMENT OF THE LEAD. A LEAD REVISION WAS PERFORMED. THE STATUS/DISPOSITION OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722310 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R UNKNOWN COMPETITOR CRT