BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23202900 · Received October 2, 2025

    Report

    Report Number
    3006630150-2025-08246
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    March 11, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED POSSIBLY 6 MONTHS AGO PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7121184. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7121268 UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43160. MODEL: SC-4316. SERIAL: BATCH: 30218445. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED POSSIBLY 6 MONTHS AGO PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43160. MODEL: SC-4316. SERIAL: BATCH: 30218445. UDI: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) WAS NO LONGER WORKING AS INTENDED AND WAS NOT HOLDING A CHARGE. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. NOTHING WILL BE RETURNED PER FACILITY POLICY. ADDITIONAL INFORMATION STATED THAT ONE OF THE LEADS HAD MIGRATED THROUGH FLUOROSCOPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) WAS NO LONGER WORKING AS INTENDED AND WAS NOT HOLDING A CHARGE. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. NOTHING WILL BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425951 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 566241 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention