BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25052701 · Received April 30, 2026

    Report

    Report Number
    3006630150-2026-02782
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. D6: EXPLANT DATE: UNKNOWN DATE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2408-56. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7072979. MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2408-56. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7075620. MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540890 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 534280 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention