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

Model Number	SC-2317-50
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient spinal cord stimulation (scs) lead has high impedances.Lead fractured was noted.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: product code: qrb.Additional suspect medical device component involved in the event: model number/catalog number: sc-2317-50.Serial number: (b)(6).Batch/lot number: 3121995.Model/catalog description: infinion cx lead kit, 50cm.Unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: product code: qrb.Additional suspect medical device component involved in the event: model number/catalog number: sc-2317-50, serial number: (b)(6), batch/lot number: 3121995, model/catalog description: infinion cx lead kit, 50cm, unique identifier (udi) #: (b)(4).Investigation results; device not returned; no analysis performed.Complaint not confirmed through physical evaluation.Device history record (dhr): a review of the device history record confirmed that the device met all required specifications prior to shipment.No manufacturing deviations, nonconformances, or process anomalies were identified that could have contributed to the reported issue.Labeling review: a review of the device labeling was performed and found to be adequate.The labeling contains appropriate instructions for use and does not indicate any deficiencies that could have contributed to the reported event.Investigation conclusion: due to the unavailability of the device for analysis and the inability to confirm the reported issue through record review, a definitive root cause could not be established.There was no evidence identified from manufacturing or labeling reviews that would suggest a contributing factor.
Event or Problem Description
It was reported that the patient spinal cord stimulation (scs) lead has high impedances.Lead fractured was noted.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event block d2b: product code: qrb additional suspect medical device component involved in the event: model number/catalog number: sc-2317-50 serial number: (b)(6).Batch/lot number: 3121995 model/catalog description: infinion cx lead kit, 50cm unique identifier (udi) #: (b)(4).Investigation results; device not returned; no analysis performed.Complaint not confirmed through physical evaluation.Device history record (dhr): a review of the device history record confirmed that the device met all required specifications prior to shipment.No manufacturing deviations, nonconformances, or process anomalies were identified that could have contributed to the reported issue.Labeling review: a review of the device labeling was performed and found to be adequate.The labeling contains appropriate instructions for use and does not indicate any deficiencies that could have contributed to the reported event.Investigation conclusion: due to the unavailability of the device for analysis and the inability to confirm the reported issue through record review, a definitive root cause could not be established.There was no evidence identified from manufacturing or labeling reviews that would suggest a contributing factor.
Event or Problem Description
It was reported that the patient spinal cord stimulation (scs) lead has high impedances.Lead fractured was noted.Additional information received that the patient had all components explanted and was doing well postoperatively.

• Brand Name: INFINION? CX
• 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: 24847361
• Report Number: 3006630150-2026-02242
• Device Sequence Number: 12993558
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: (01)08714729861614(17)181130(10)20014786
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 06/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 20014786
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/16/2026; 05/18/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/11/2026; 06/10/2026
• Date Device Manufactured: 11/30/2016
• 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: 55 YR
• Patient Sex: Female