BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15719453 · Received November 3, 2022

    Report

    Report Number
    3006630150-2022-05940
    Event Type
    Injury
    Date Received
    November 3, 2022
    Date of Event
    October 6, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352700; MODEL: SC-2352-70; SERIAL: (B)(4); BATCH: 7074529. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352700; MODEL: SC-2352-70; SERIAL: (B)(4); BATCH: 7074584. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352500; MODEL: SC-2352-50; SERIAL: (B)(4); BATCH: 7073454. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352500; MODEL: SC-2352-50; SERIAL: (B)(4); BATCH: 7073737.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED A CHANGE IN COGNITION IN WHICH SHE APPEARED FORGETFUL POSTOPERATIVELY FROM A PROCEDURE (SEE MFR REPORT 3006630150-2022-05822). THE PATIENT REMAINED HOSPITALIZED AFTER THE PROCEDURE. THE PHYSICIAN DOES NOT BELIEVE PATIENTS SYMPTOMS ARE DEVICE RELATED, HOWEVER HE WAS UNSURE IF IT WAS RELATED TO THE ANESTHESIA USED FOR THE PROCEDURE. MAGNETIC RESONANCE IMAGING (MRI) RESULTS WERE INCONCLUSIVE. ADDITIONALLY, THE PATIENT EXPERIENCED SUPERFICIAL CELLULITIS AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD INCISION SITES. THERE WAS NO APPEARANCE OF REDNESS OR DISCHARGE AND NO CULTURE WAS TAKEN, HOWEVER THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788822 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 537918 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H