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

Model Number	SC-1010C
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred three years prior to the date the manufacturer became aware.Block d2b: pro code (product code): qrb.This product was manufactured prior to implementation of the unique identifier (udi) regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that the implantable pulse generator (ipg) would no longer charge.The patient underwent an implantable pulse generator (ipg) replacement procedure and was doing well postoperatively.The explanted device was discarded by the medical facility.No device malfunction was suspected.
Additional Manufacturer Narrative
The prior report incorrectly stated, this product was manufactured prior to implementation of the unique identifier (udi) regulation and as a result, the complete udi is not available.This report is being submitted to remove this incorrect statement from the additional mfr narrative field (h11) in section h, device manufacturers only.Block b3: exact date unknown, event occurred three years prior to the date the manufacturer became aware.Block d2b: pro code (product code): qrb.
Event or Problem Description
It was reported that the implantable pulse generator (ipg) would no longer charge.The patient underwent an implantable pulse generator (ipg) replacement procedure and was doing well postoperatively.The explanted device was discarded by the medical facility.No device malfunction was suspected.

• Brand Name: PRECISION?
• 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: 23198185
• Report Number: 3006630150-2025-08223
• Device Sequence Number: 9159929
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 10/01/2013
• Device Model Number: SC-1010C
• Device Catalogue Number: SC-1010C
• Device Lot Number: 14793704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 05/20/2026
• 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: 60 YR
• Patient Sex: Male