BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8-CHANNEL ADAPTER, BSX, 10CM

    MDR report key: 18084576 · Received November 7, 2023

    Report

    Report Number
    1627487-2023-05271
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 7, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067016713
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS POCKET ADAPTER, MODEL: 2321, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7100084. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IPG REPLACEMENT ON (B)(6) 2023 (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-03951) THERE WERE HIGH IMPEDANCES ON CONTACTS 1-8 WHEN THEY WERE CONNECTED TO THE NEW IPG. AS SUCH, THE ADAPTER WAS EXPLANTED AND REPLACED IT WITH A NEW 2321 ADAPTER. THERE WERE FEWER HIGH IMPEDANCES WITH THE NEW ADAPTER. PROCEDURE WAS COMPLETED AND PATIENT HAD EFFECTIVE THERAPY POST-OP. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE ADAPTER ATTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351325 8-CHANNEL ADAPTER, BSX, 10CM SCS POCKET ADAPTER LGW ABBOTT MEDICAL 2321 7100084 05415067016713

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS IPG| SCS POCKET ADAPTER