BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25322694 · Received May 28, 2026

    Report

    Report Number
    3006630150-2026-03573
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    January 21, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5077185. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-70. BATCH/LOT NUMBER: 5079196. SERIAL NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-25. BATCH/LOT NUMBER: 7041610. SERIAL NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-25. BATCH/LOT NUMBER: 7043041. SERIAL NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-25. BATCH/LOT NUMBER: 7048412. SERIAL NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-3138-25. BATCH/LOT NUMBER: 7051382. SERIAL NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND HIGH IMPEDANCES ON THE LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED IPG WAS DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243302 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 569490 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1