BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 14781895 · Received June 22, 2022

    Report

    Report Number
    3006630150-2022-03057
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    May 30, 2022
    Report Date
    August 5, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 7071704. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 7072189.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK D6B. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7071704. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072189.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND WANTED TO HAVE THE SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANTED. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT HAS FULLY RECOVERED POST-OPERATIVELY. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND WANTED TO HAVE THE SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANTED. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT HAS FULLY RECOVERED POST-OPERATIVELY. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT NUMEROUS REPROGRAMMING'S WERE ATTEMPTED PRIOR TO THE EXPLANT PROCEDURE HOWEVER, THE PATIENTS PAIN RELIEF REMAINED INADEQUATE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307551 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 373540 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention