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

Model Number	SC-2317-70
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients spinal cord stimulation (scs) leads had high impedances.The patient underwent a scs system explant procedure and was doing well postoperatively.The explanted devices were not returned.
Event or Problem Description
It was reported that the leads had high impedances.The patient underwent a spinal cord stimulator (scs) system explant procedure and was doing well postoperatively.The explanted devices were discarded by the facility.
Additional Manufacturer Narrative
D2b pro code (product code): qrb additional suspect medical device components involved in the event: model: infinion cx lead kit, 70cm model number: sc-2317-70 upn: m365sc2317700 serial: (b)(6) batch: 7077734 udi:(b)(4) model: wavewriter alpha 32 ipg kit model number: sc-1232 upn: m365sc12320 serial: (b)(6) batch: 532689 udi: (b)(4) model: clik x anchor sterile kit model number: sc-4318 upn: m365sc43180 batch: 28093988 udi: (b)(4).
Additional Manufacturer Narrative
D2b pro code (product code): qrb.Additional suspect medical device components involved in the event: model: infinion cx lead kit, 70cm, model number: sc-2317-70, upn: m365sc2317700, serial: (b)(6), batch: 7077734, udi: (b)(4).Model: wavewriter alpha 32 ipg kit, model number: sc-1232, upn: m365sc12320, serial: (b)(6), batch: 532689, udi: (b)(4).Model: clik x anchor sterile kit, model number: sc-4318, upn: m365sc43180, batch: 28093988, udi: (b)(4).Investigation results, media review, device analysis the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.

• 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; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50490374
• Report Number: 3006630150-2026-06229
• Device Sequence Number: 15967742
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: (01)08714729861638(17)240110(10)7077637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 01/10/2024
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7077637
• 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: 07/29/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 01/10/2022
• 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: 65 YR
• Patient Sex: Male