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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported by the patient's daughter that the patient passed away.The patients daughter advised that the cause of death was not spinal cord stimulation (scs) device related.
Additional Manufacturer Narrative
A review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.The device was not returned to boston scientific for analysis and the complaint as reported was not able to be confirmed.Therefore, the root cause of the reported event could not be established.
Event or Problem Description
It was reported by the patients daughter that the patient passed away.The patients daughter advised that the cause of death was not spinal cord stimulation (scs) device related.

• 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 ; +1(763)292-0920
• MDR Report Key: 25445432
• Report Number: 3006630150-2026-03932
• Device Sequence Number: 5764333
• Product Code: LGW
• UDI-Device Identifier: 08714729861539
• UDI-Public: (01)08714729861539(17)180808(10)150509
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/08/2018
• Device Model Number: SC-1032B
• Device Catalogue Number: SC-1032B
• Device Lot Number: 150509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 08/08/2016
• 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: Death
• Patient Age: 89 YR
• Patient Sex: Female