BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 21501969 · Received March 3, 2025

    Report

    Report Number
    3006630150-2025-01146
    Event Type
    Injury
    Date Received
    March 3, 2025
    Date of Event
    January 4, 2024
    Report Date
    April 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7131565. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7131891. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN LEAD EXTENSIONS WERE ALSO ADDED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MIGRATED SPINAL CORD STIMULATION (SCS) LEADS WERE ALSO REVISED, DURING POCKET REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN LEAD EXTENSIONS WERE ALSO ADDED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777235 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 579189

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention