BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 9846382 · Received March 18, 2020

    Report

    Report Number
    3006630150-2020-01248
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5065091/5081637. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING WORSENING LOW BACK PAIN THAT RADIATES DOWN THE LEGS. THE PATIENT WAS GIVEN MUSCLE RELAXERS FOR THE PAIN, BUT IT NEVER HELPED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING WORSENING LOW BACK PAIN THAT RADIATES DOWN THE LEGS. THE PATIENT WAS GIVEN MUSCLE RELAXERS FOR THE PAIN BUT IT NEVER HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311103 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 16447695 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention