BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20561570 · Received October 29, 2024

    Report

    Report Number
    3006630150-2024-07402
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 5025005 BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 5012569 BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 5025260.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING MUCH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS). THE PATIENT TURNED OFF THE SCS DEVICE AND DID NOT NOTICE MUCH OF A DIFFERENCE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS REMOVED. POST OPERATIVELY, THE PATIENT WAS RECOVERING AS EXPECTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924003 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 206225 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention