MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2316-50
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: infinion 16, upn: m365sc2316500, model: sc-2316-50, serial: (b)(6), batch: 17326196.Brand name: precision spectra.Upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: 17603967.
Event or Problem Description
It was reported that the patient experienced pain at the implantable pulse generator (ipg) site and spinal cord stimulation (scs) leads displayed high impedances which led to inadequate stimulation as the impeded contacts were needed to get coverage of her pain.It was assessed that the high impedance contacts may have possibly caused the pain at the ipg site.The patient underwent a procedure where the ipg and leads were removed and replaced.The ipg site was changed from left gluteal to left flank.Post operatively, the patient was doing well.The explanted devices will not be returned as they were disposed by the hospital.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: infinion 16, upn: m365sc2316500, model: sc-2316-50, serial: (b)(6), batch: 17326196.Brand name: precision spectra upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: 17603967.
Event or Problem Description
It was reported that the patient experienced pain at the implantable pulse generator (ipg) site and spinal cord stimulation (scs) leads displayed high impedances which led to inadequate stimulation as the impeded contacts were needed to get coverage of her pain.It was assessed that the high impedance contacts may have possibly caused the pain at the ipg site.The patient underwent a procedure where the ipg and leads were removed and replaced.The ipg site was changed from left gluteal to left flank.Post operatively, the patient was doing well.The explanted devices will not be returned as they were disposed by the hospital.Additional information was received that following the procedure, the patient had a hematoma and swelling, which was managed by wound checks and dressing change, and has now fully healed.

• Brand Name: INFINION 16
• 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: 24300677
• Report Number: 3006630150-2026-00799
• Device Sequence Number: 5266075
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: 08714729797814
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 12/10/2017
• Device Model Number: SC-2316-50
• Device Catalogue Number: SC-2316-50
• Device Lot Number: 17674693
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 02/10/2015
• 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: 62 YR
• Patient Sex: Female