BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20593936 · Received November 2, 2024

    Report

    Report Number
    3006630150-2024-07524
    Event Type
    Injury
    Date Received
    November 2, 2024
    Date of Event
    October 10, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6). BATCH: 7081693 AND 7086556.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: 7081693 AND 7086556. BATCH: 7081693 AND 7086556. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: NOT APPLICABLE. BATCH: 34066626.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT ATTENDED THE FOLLOW UP APPOINTMENT THE DAY AFTER THE IMPLANT OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM IT WAS DISCOVERED THAT THE PATIENT WAS UNABLE TO WALK. THE PATIENT WAS REFERRED TO THE HOSPITAL WARD AND IT WAS DETERMINED THAT THEIR LEGS WERE UNSTEADY AND THERE WAS PAIN IN THE HIP CONTRIBUTING TO THE INABILITY TO WALK. IMAGING WAS PERFORMED BUT THE CAUSE OF THE PATIENT EFFECT WAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PATIENT ATTENDED THE FOLLOW UP APPOINTMENT THE DAY AFTER THE IMPLANT OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM IT WAS DISCOVERED THAT THE PATIENT WAS UNABLE TO WALK. THE PATIENT WAS REFERRED TO THE HOSPITAL WARD AND IT WAS DETERMINED THAT THEIR LEGS WERE UNSTEADY AND THERE WAS PAIN IN THE HIP CONTRIBUTING TO THE INABILITY TO WALK. IMAGING WAS PERFORMED BUT THE CAUSE OF THE PATIENT EFFECT WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773349 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 765603 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male Other| H