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

Model Number	SC-1132
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Implant Pain (4561)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date unknown, event occurred a couple of years from the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-linear leads; upn: m365sc2316700; model: sc-2316-70; serial: (b)(4); batch: 16692623.
Event or Problem Description
It was reported that the patient was experiencing pain at the ipg site and inadequate pain relief.The patient underwent an explant procedure.The explanted ipg and leads were not returned to bsn as they were discarded by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-splitters upn: m365sc3400300 model: sc-3400-30 serial: (b)(6).Batch: 16667023 udi: (b)(4).
Event or Problem Description
It was reported that the patients was experiencing pain at the ipg site and inadequate pain relief.The patient underwent an explant procedure.The explanted devices were not returned to bsn as they were discarded by the medical facility.

• 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: 15374501
• Report Number: 3006630150-2022-04594
• Device Sequence Number: 12154308
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: (01)08714729797838(17)160123(10)16667023
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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): 11/12/2025

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: 01/17/2016
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 16662571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2014
• 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: 39 YR
• Patient Sex: Female