BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 13665867 · Received March 4, 2022

    Report

    Report Number
    3006630150-2022-00838
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    January 11, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED A MONTH AGO FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: M365SC2218700. SERIAL: (B)(6). BATCH: 5024682/5030912.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS EXPLANTED DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG WAS EXPLANTED DUE TO AN UKNOWN REASON. ADDITIONAL INFORMATION THAT THE LEADS WERE REMOVED DURING THE EXPLANTED PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962648 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 21534826 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention