BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 10960844 · Received December 7, 2020

    Report

    Report Number
    3006630150-2020-06051
    Event Type
    Injury
    Date Received
    December 7, 2020
    Date of Event
    August 5, 2014
    Report Date
    December 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN:M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH:16985330. PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH:16985330.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IMPLANT PROCEDURE, THE PATIENT COULD NOT WALK AND WAS SENT TO A NURSING HOME FOR AT LEAST TWO MONTHS. THE PATIENT IS EXPERIENCING PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE TO THE GROIN AND DOWN TO THE KNEE. THE PATIENT REPORTED HE HAD BEEN TO THE EMERGENCY ROOM SEVERAL TIMES FOR PAIN AND CANNOT WALK AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425130 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 17076382 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other