BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12768375 · Received November 8, 2021

    Report

    Report Number
    3006630150-2021-06288
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    July 27, 2021
    Report Date
    November 8, 2021
    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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317500; MODEL: SC-2317-50; SERIAL: (B)(4); BATCH: 7070842.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING INADEQUATE PAIN RELIEF. IT WAS ALSO MENTIONED THAT A BSN REPRESENTATIVE REPROGRAMMED THE PATIENT AND THERE WERE CONTACTS OUT SHOWN ON THE INFINION LEADS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. THE EXPLANTED DEVICES WERE COLLECTED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665908 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5178643 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention