MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Precision?; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-1110-02
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Fluid Discharge (2686)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's implanted pulse generator (ipg) was unable to charge.The patient subsequently underwent a surgical procedure.During the procedure, following incision at the battery site, a white discharge was observed, and wound irrigation specimens were obtained.The midline incision was also opened, no discharge was noted at that location.However, the physician observed granulation tissue beneath the currently implanted paddle lead.Given these findings, the physician elected not to implant new equipment and instead explanted the existing system.The physician reportedly did not believe the probable infection was device related and instead suspected an underlying inflammatory condition.Culture was obtained and the result was not yet available.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: additional applicable product code: qrb additional suspect medical device component involved in the event: model number/catalog number: sc-8216-70.Serial number: (b)(6).Batch/lot number: 15085518.Model/catalog description: artisan lead 70 cm.Unique identifier (udi): (b)(6).

• 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50841698
• Report Number: 3006630150-2026-06939
• Device Sequence Number: 10301447
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• 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: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 06/01/2014
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 15299619
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: 69 YR
• Patient Sex: Male