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

Model Number	SC-2316-70
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a car accident, the patients spinal cord stimulation (scs) leads displayed high impedances.Programming optimization around the impedances initially worked; however, over time, the stimulation became less effective.The patient underwent a procedure where the system was explanted and replaced with a new system.The patient was recovering with adequate stimulation postoperatively.The leads and lead splitters were discarded by the medical facility and will not be returned.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: infinion 16.Upn: m365sc2316700.Model: sc-2316-70.Serial: (b)(6).Batch: 20291135.Brand name: n/a.Upn: m365sc3400300.Model: sc-3400-30.Serial: (b)(6).Batch: 20465524.Brand name: n/a.Upn: m365sc3400300.Model: sc-3400-30.Serial: (b)(6).Batch: 2000020363.Brand name: precision spectra.Upn: m365sc11320.Model: sc-1132.Serial: (b)(6).Batch: 20775598.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: infinion 16, upn: m365sc2316700, model: sc-2316-70, serial: (b)(6), batch: 20291135.Brand name: n/a, upn: m365sc3400300, model: sc-3400-30, serial: (b)(6), batch: 20465524.Brand name: n/a.Upn: m365sc3400300.Model: sc-3400-30.Serial: (b)(6), batch: 2000020363.Brand name: precision spectra, upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: 20775598.
Event or Problem Description
It was reported that following a car accident, the spinal cord stimulation (scs) leads displayed high impedances.Programming optimization around the impedances initially worked; however, over time, the stimulation became less effective.The patient underwent a procedure where the system was explanted and replaced with a new system.The patient was recovering with adequate stimulation postoperatively.The leads and lead splitters were discarded by the medical facility and will not be returned.Additional information was received indicating that portions of the devices were returned and are currently pending analysis.
Event or Problem Description
It was reported that following a car accident, the spinal cord stimulation (scs) leads displayed high impedances.Programming optimization around the impedances initially worked; however, over time, the stimulation became less effective.The patient underwent a procedure where the system was explanted and replaced with a new system.The patient was recovering with adequate stimulation postoperatively.The leads and lead splitters were discarded by the medical facility and will not be returned.Additional information was received indicating that portions of the devices were returned and are currently pending analysis.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: infinion 16, upn: m365sc2316700, model: sc-2316-70, serial: (b)(6), batch: 20291135.Brand name: n/a, upn: m365sc3400300, model: sc-3400-30, serial: (b)(6), batch: 20465524.Brand name: n/a, upn: m365sc3400300, model: sc-3400-30, serial: (b)(6), batch: 2000020363.Brand name: precision spectra, upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: 20775598.With all available information, boston scientific concludes that the reported event is a known inherent risk as documented in the instructions for use (ifu).The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.The returned portions of lead sc-2316-70 sn (b)(6) revealed that the leads were cleanly cut into two pieces near the proximal end of the leads and the distal portion of the leads were not returned.The clean-cut damage is a result of a typical explant procedure and is not considered a failure.No other anomalies were identified on the returned portion of the leads aside from the clean-cut.The returned lead splitters sc-3400-30 sn (b)(6) revealed that they were cleanly cut into three pieces near the proximal end of the lead.The clean-cut damage is a result of a typical explant procedure and is not considered a failure.The electrical test could not be performed due to the cut lead body.No other anomalies were identified on the returned portion of the lead splitters.A product labeling review identified that the devices were used per the instructions for use (ifu) product label.Additionally, system failure, can occur at any time due to random failure(s) of the components.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure, all of which are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.

• 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: 22129635
• Report Number: 3006630150-2025-03885
• Device Sequence Number: 12623811
• Product Code: LGW
• UDI-Device Identifier: 08714729797821
• UDI-Public: (01)08714729797821(17)190425(10)20565162
• 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: 2017
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 09/17/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/25/2019
• Device Model Number: SC-2316-70
• Device Catalogue Number: SC-2316-70
• Device Lot Number: 20565162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 08/25/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/21/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2017
• 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: 59 YR
• Patient Sex: Female