BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA IPG

    MDR report key: 11630919 · Received April 7, 2021

    Report

    Report Number
    2182208-2021-01365
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 7, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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) YEARS OLD. 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: LONG-TERM TECHNICAL PERFORMANCE OF THE OSYPKA QT-5 VENTRICULAR PACEMAKER LEAD. JOURNAL OF CLINICAL MEDICINE. 2021. 10, 639. DOI.ORG/10.3390/JCM10040639. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING PACEMAKERS. THE ARTICLE REPORTS PATIENTS WHO EXPERIENCED HEMATOMAS AND SUBCLINICAL OR OLIGOSYMPTOMATIC PNEUMOTHORAX WHICH WERE TREATED CONSERVATIVELY. THERE WERE OTHER PATIENTS THAT NEEDED REOPERATIONS OR REVISIONS DUE TO INFECTION, LOOSE SET SCREW, RIGHT ATRIAL (RA) LEAD DISLODGEMENT, CHRONIC POCKET PAIN, AND RA LEAD DYSFUNCTION. 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 YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528296 SENSIA IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R OSYPKA LEAD