BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11076267 · Received December 28, 2020

    Report

    Report Number
    3006630150-2020-06421
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    December 10, 2020
    Report Date
    December 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(4). BATCH: 7072486

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TIGHT SENSATIONS ON THE LEAD INCISION SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN ADJUSTED THE TENSION LOOP ON THE PATIENTS MIDLINE INCISION. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540334 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 3208353 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention