BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 18401290 · Received December 27, 2023

    Report

    Report Number
    3006630150-2023-08174
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    September 1, 2023
    Report Date
    April 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY SEPTEMBER OF 2023 FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5096845. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5060627/5033173.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS LEAD HAD A FRACTURED DUE TO A CAR ACCIDENT. IT WAS MENTION ALSO THAT MULTIPLE CONTACTS WERE OUT AND PATIENTS LEAD HAD MIGRATED ALSO. IT WAS MENTION THAT PATIENT EXPERIENCE INADEQUATE STIMULATION. ADDITIONAL INFORMATION RECEIVED THAT PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED AND WILL NOT BE RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS LEAD HAD A FRACTURED DUE TO A CAR ACCIDENT. IT WAS MENTION ALSO THAT MULTIPLE CONTACTS WERE OUT AND PATIENTS LEAD HAD MIGRATED ALSO. IT WAS MENTION THAT PATIENT EXPERIENCE INADEQUATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299479 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5096775 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention