BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 10759510 · Received October 29, 2020

    Report

    Report Number
    3006630150-2020-05229
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    May 1, 2019
    Report Date
    November 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6 PATIENT CODE 3191: NO CODE AVAILABLE WAS USED BECAUSE THERE IS NOT AN EQUIVALENT FDA CODE FOR SURGICAL INTERVENTION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 20475809. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7021466.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE NEED FOR AN MRI FOR A GASTROINTESTINAL ISSUE THAT WAS UNRELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218128 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 206521

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention