BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20613819 · Received November 5, 2024

    Report

    Report Number
    3006630150-2024-07572
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    May 1, 2024
    Report Date
    March 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 15651190. PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 15891064.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 15651190. PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 15891064.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO AN ELECTIVE UPGRADE FOR MAGNETIC RESONANCE IMAGING (MRI) ACCESS AND CHARGING DIFFICULTIES. ALSO, THERE WAS INADEQUATE PLACEMENT FOR ONE PADDLE AND HIGH IMPEDANCES ON THE OTHER PADDLE. SALES REPRESENTATIVE WAS ABLE TO MAINTAIN COVERAGE IN PAIN AREAS DURING POST OPERATIVELY APPOINTMENT. EXPLANTED DEVICES WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS USED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO AN ELECTIVE UPGRADE FOR MAGNETIC RESONANCE IMAGING (MRI) ACCESS AND CHARGING DIFFICULTIES. ALSO, THERE WAS INADEQUATE PLACEMENT FOR ONE PADDLE AND HIGH IMPEDANCES ON THE OTHER PADDLE. SALES REPRESENTATIVE WAS ABLE TO MAINTAIN COVERAGE IN PAIN AREAS DURING POST OPERATIVELY APPOINTMENT. EXPLANTED DEVICES WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405232 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 16377138 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention