MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SPECTRA WAVEWRITER?; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-1060-B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) system underwent a revision procedure for an unknown reason.The current location of the device remains unknown.No additional information was available.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) system underwent a revision procedure for an unknown reason.The current location of the device remains unknown.No additional information was available.Additional information indicates that the spinal cord stimulation (scs) device was explanted as part of an elective procedure, per patients request due to discontinued use of the device.No additional adverse patient effects were reported.The explanted device will not be returned as it was disposed per facility policy.Since there are no reportable allegations against the device and no serious injury occurred, this complaint has been downgraded to non-reportable based on these criteria.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.

• Brand Name: SPECTRA WAVEWRITER?
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22493961
• Report Number: 3006630150-2025-05454
• Device Sequence Number: 8188253
• Product Code: LGW
• UDI-Device Identifier: 08714729953432
• UDI-Public: (01)08714729953432(17)210218(10)350832
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/18/2021
• Device Model Number: SC-1060-B
• Device Catalogue Number: SC-1060-B
• Device Lot Number: 350832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/10/2025
• Date Device Manufactured: 02/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female