BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15184095 · Received August 8, 2022

    Report

    Report Number
    3006630150-2022-03902
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7070918. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7071118. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 SERIAL: N/A BATCH: 25168242

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLANT OF THEIR ENTIRE SPINAL CORD STIMULATION SYSTEM DUE TO AN UNKNOWN REASON. BOSTON SCIENTIFIC WAS UNABLE TO FIND OUT THE REASON FOR THE EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE NOT RELEASED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531061 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 367681 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention