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 Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred two years ago from the date the manufacturer was made aware.Block d.2b; additional applicable product code: lgw, qrb additional suspect medical device component involved in the event: model number/catalog number: sc-2317-70, serial number: (b)(6), batch/lot number: 7083020, model/catalog description: infinion cx lead kit, 70cm, unique identifier (udi) #: (b)(4).Sc-2317-70 (sn (b)(6)) investigation results, media review, device analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.The photo provided by the customer confirms that there is high impedance.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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Sc-2317-70 (sn (b)(6)) investigation results, media review, device analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.According to media inspection of the picture provided by the customer, high impedances were verified.The complaint was confirmed.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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that after a fall, it was found out that the right lead had two impedances and the lead had possibly migrated but was unable to confirm it.After program optimization, the patient got good coverage.

• 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: 50910714
• Report Number: 3006630150-2026-07137
• Device Sequence Number: 5330277
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: (01)08714729861638(17)250801(10)7083112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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: 08/01/2025
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7083112
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 08/02/2023
• 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: Other
• Patient Age: 83 YR
• Patient Sex: Male