BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC IPG

    MDR report key: 13052859 · Received December 21, 2021

    Report

    Report Number
    2182208-2021-05017
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 21, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. 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/66 YEARS OLD. 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 WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ANALYZING THE IMPACT OF PREOPERATIVE INTERROGATION OF CARDIAC IMPLANTABLE ELECTRONIC DEVICES. ANNALS OF CARDIAC ANAESTHESIA. 2021; 24:447-51. DOI: 10.4103/ACA.ACA_32_20. 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 THE IMPACT OF PREOPERATIVE INTERROGATION OF CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICES (CIED). THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED PERIOPERATIVE CARDIAC EVENTS (INTRA- AND POSTOPERATIVE) SUCH AS UNCONTROLLED INTRAOPERATIVE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR), SYMPTOMATIC SINUS BRADYCARDIA WITH MULTIPLE INAPPROPRIATE DEVICE SHOCKS, LOSS OF BIVENTRICULAR CAPTURE, SYMPTOMATIC ATRIAL TACHYCARDIA, NEW ONSET LEFT BUNDLE BRANCH BLOCK, SYMPTOMATIC BIGEMINY, TORSADES DES POINTES, SYMPTOMATIC SINUS TACHYCARDIA, AND SYMPTOMATIC PREMATURE VENTRICULAR CONTRACTIONS (PVC); THESE OCCURRED WITH ELECTIVE AND EMERGENT PROCEDURES. THERE WERE ALSO CIED RELATED DELAYS IN SURGERIES. PATIENTS WITH PERIOPERATIVE CARDIAC EVENTS WERE ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR 24 HOUR OBSERVATION AND THE DEVICES WERE REASSESSED. THE STATUS/DISPOSITION OF THE DEVICES AND LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952202 MEDTRONIC IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| L UNKNOWN LEADS