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	High impedance (1291); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was unable to have a magnetic resonance imaging (mri) due to concern for abnormal lead impedance from the spinal cord stimulator (scs) device.It was also reported that the patients implantable pulse generator (ipg) was no longer keeping a charge.The patient underwent a revision procedure wherein the ipg, scs leads and clik anchor were replaced.The patient was reported to be doing well post operatively.The explanted device components were not returned due to facility policy.
Additional Manufacturer Narrative
Block d.2b; additional applicable product code: qrb additional suspect medical device components involved in the event: model number/catalog number: sc-2317-50 serial number: (b)(6) batch/lot number: 7077652 model/catalog description: infinion cx lead kit, 50cm unique identifier (udi) #: (b)(4) model number/catalog number: sc-1232 serial number: (b)(6) batch/lot number: 545316 model/catalog description: wavewriter alpha 32 ipg kit unique identifier (udi) #: (b)(4) model number/catalog number: sc-4318 serial number: n/a batch/lot number: 29661764 model/catalog description: clik x anchor sterile kit unique identifier (udi) #: (b)(4) sc-2317-50 sn: (b)(6)/ (b)(6) investigation results: the devices were not returned for analysis; therefore, a technical analysis could not be performed.Device history record it was confirmed these devices 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, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 50836113
• Report Number: 3006630150-2026-06932
• Device Sequence Number: 10060360
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/21/2026

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: 07/17/2024
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 7077615
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 07/18/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 219 LB