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 Codes	Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this spinal cord stimulation (scs) patient underwent a revision procedure due having increased charging time and also wanted magnetic resonance imaging (mri) capabilities.The implantable pulse generator (ipg) was replaced.Electrocautery was used.The patient was stable post operation and doing great.The facility kept the device and will not be releasing it back for further analysis.
Event or Problem Description
It was reported that this spinal cord stimulation (scs) patient underwent a revision procedure due having increased charging time and also wanted magnetic resonance imaging (mri) capabilities.The implantable pulse generator (ipg) was replaced.Electrocautery was used.The patient was stable post operation and doing great.The explanted ipg will not be returned as it was retained by the medical facility.
Additional Manufacturer Narrative
Investigation summary: based on the available information, the root cause of the reported event of frequent charging of the ipg cannot be established as the product has not been returned for analysis.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Device technical analysis: this ipg was not returned and as such, physical analysis has not been conducted in our laboratory.Investigation conclusion: based on limited information and in the absence of device return, the root cause of the reported event of frequent charging of the ipg cannot be established as the product has not been returned for analysis.

• 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: 25166436
• Report Number: 3006630150-2026-03127
• Device Sequence Number: 18687739
• Product Code: LGW
• UDI-Device Identifier: 08714729953432
• UDI-Public: (01)08714729953432(17)200812(10)339861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2026
• 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): 06/18/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/12/2020
• Device Model Number: SC-1060-B
• Device Catalogue Number: SC-1060-B
• Device Lot Number: 339861
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 08/13/2018
• 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: 74 YR
• Patient Sex: Female