BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA SERIES

    MDR report key: 20734243 · Received November 20, 2024

    Report

    Report Number
    9614453-2024-04539
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. REFERENCED ARTICLE: TRANSIENT PHRENIC NERVE STIMULATION IN A PATIENT WITH SINGLE CHAMBER PACEMAKER: CASE REPORT. JOURNAL OF ARRHYTHMOLOGY. 2024; 31(2): 68-72. DOI: 10.35336/VA-1290. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THIS IMPLANTABLE PULSE GENERATOR (IPG). THE AUTHORS DESCRIBED A PATIENT WHO HAD A DEVICE REPLACEMENT DUE TO A FAILURE OF THE IPG. THE STATUS OF THE DEVICE IS UNKNOWN. NO ADVERSE PATIENT EFFECTS OR ADDITIONAL PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070132 MEDTRONIC.SIGMA SERIES PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC EUROPE SARL SSR303U

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H BIOTRONIK PX-60-BP LEAD