BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 12048225 · Received June 23, 2021

    Report

    Report Number
    3006630150-2021-03149
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8120700, MODEL: SC-8120-70, SERIAL: (B)(4), BATCH: 259360A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ALL DEVICE COMPONENTS WERE EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949064 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 19089492 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention