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

Model Number	SC-1032B
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that this spinal cord stimulation (scs) device was replaced due to an unknown reason.The location of the device is unknown.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
B3: estimated based on gfe response from sales representative.
Event or Problem Description
It was reported that this spinal cord stimulation (scs) device was replaced due to an unknown reason.The location of the device is unknown.No additional adverse patient effects were reported.Additional information was received stating that the scs patient underwent the replacement procedure due to discontinuation of implantable pulse generator (ipg) use for over two years, which resulted in an unresponsive ipg.Electrocautery was used.The ipg was retained by the hospital and will not be returned for analysis.
Additional Manufacturer Narrative
B3: estimated based on gfe response from sales representative.
Event or Problem Description
It was reported that this spinal cord stimulation (scs) device was replaced due to an unknown reason.The location of the device is unknown.No additional adverse patient effects were reported.Additional information was received stating that the scs patient underwent the replacement procedure due to discontinuation of implantable pulse generator (ipg) use for over two years, which resulted in an unresponsive ipg.Electrocautery was used.The ipg was retained by the hospital and will not be returned for analysis.Additional information was received that the scs replacement was performed in accordance with the physician and patient decision.

• Brand Name: PRECISION SPECTRA?
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23716136
• Report Number: 3006630150-2025-11177
• Device Sequence Number: 13323142
• Product Code: LGW
• UDI-Device Identifier: 08714729861539
• UDI-Public: (01)08714729861539(17)170705(10)132176
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup
• Report Date (Section B): 02/10/2026

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: 07/05/2017
• Device Model Number: SC-1032B
• Device Catalogue Number: SC-1032B
• Device Lot Number: 132176
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/20/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/06/2026; 02/10/2026
• Date Device Manufactured: 07/06/2015
• 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