BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11569516 · Received March 25, 2021

    Report

    Report Number
    3006630150-2021-01207
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    November 18, 2020
    Report Date
    April 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION SINCE THE IMPLANT PROCEDURE. MULTIPLE REPROGRAMMING ATTEMPTS WERE PERFORMED BUT THE ISSUE WAS NOT RESOLVED. THE PATIENT UNDERWENT A PROCEDURE TO IMPLANT A THORACIC SURGICAL PADDLE LEAD AND POST-OPERATIVELY THE PATIENT WAS RECEIVING GREAT PARESTHESIA COVERAGE OF ALL PAIN AREAS. SINCE THE REVISION, THE PATIENT REPORTS ZERO PERCENT PAIN RELIEF EVEN WITH CONTINUED GREAT COVERAGE. THE PATIENT HAS DECLINED FURTHER REPROGRAMMING AND HAS DECIDED TO NO LONGER USE THE STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN ORDERED A THORACIC AND LUMBAR BONE SCAN. AN APPOINTMENT HAS BEEN SET FOR THE PATIENT TO BE FITTED FOR A BACK BRACE AND THE PHYSICIAN DOES NOT PLAN TO EXPLANT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7070466. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7071772.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION SINCE THE IMPLANT PROCEDURE. MULTIPLE REPROGRAMMING ATTEMPTS WERE PERFORMED BUT THE ISSUE WAS NOT RESOLVED. THE PATIENT UNDERWENT A PROCEDURE TO IMPLANT A THORACIC SURGICAL PADDLE LEAD AND POST-OPERATIVELY THE PATIENT WAS RECEIVING GREAT PARESTHESIA COVERAGE OF ALL PAIN AREAS. SINCE THE REVISION, THE PATIENT REPORTS ZERO PERCENT PAIN RELIEF EVEN WITH CONTINUED GREAT COVERAGE. THE PATIENT HAS DECLINED FURTHER REPROGRAMMING AND HAS DECIDED TO NO LONGER USE THE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464938 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 372376 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention