BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24730989 · Received March 30, 2026

    Report

    Report Number
    3006630150-2026-01915
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2408-56. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: (B)(6). 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: (B)(6). MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). SC-1216 (SN (B)(6)). SC-2408-56 (SN (B)(6)). SC-2408-56 (SN (B)(6)). INVESTIGATION RESULT: THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. LABELING REVIEW: A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES: "UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE." AND "PERSISTENT PAIN AT THE IPG OR LEAD SITE." ARE A KNOWN RISKS WITH THE USE OF SPINAL CORD STIMULATION (SCS). INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2408-56. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: (B)(6). 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: (B)(6). 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 WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. FACILITY DISPOSED OF THE PRODUCT EXPLANTED PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. FACILITY DISPOSED OF THE PRODUCT EXPLANTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71191 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 802905 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1