BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11898330 · Received May 27, 2021

    Report

    Report Number
    3006630150-2021-02445
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    January 15, 2021
    Report Date
    August 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 7081797/7081534.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WITH THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DESPITE REPROGRAMMING ATTEMPTS. THE PATIENT RECEIVED AN INJECTION THAT THE PATIENT THOUGHT IT ONLY HELPED INITIALLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS PAIN WAS LOCATED AT THE LOW BACK AS WELL AS AT THE IPG SITE. IT WAS BELIEVED THAT THE PATIENTS PAIN WAS DEVICE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WITH THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DESPITE REPROGRAMMING ATTEMPTS. THE PATIENT RECEIVED AN INJECTION THAT THE PATIENT THOUGHT IT ONLY HELPED INITIALLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS PAIN WAS LOCATED AT THE LOW BACK AS WELL AS AT THE IPG SITE. IT WAS BELIEVED THAT THE PATIENTS PAIN WAS DEVICE RELATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY AND THE EXPLANTED SCS SYSTEM WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN WITH THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DESPITE REPROGRAMMING ATTEMPTS. THE PATIENT RECEIVED AN INJECTION THAT THE PATIENT THOUGHT IT ONLY HELPED INITIALLY .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789934 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 374647 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention