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	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was no longer getting a relief due to lead migration that was confirmed via x-ray.All components were explanted.No further information has been obtained.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product code: lgw, qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-2317-70.Serial number: (b)(6).Batch/lot number: 20984725.Model/catalog description: infinion cx lead kit, 70cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-1132.Serial number: (b)(6).Batch/lot number: 20600836.Model/catalog description: precision spectra ipg kit.Unique identifier (udi) #: (b)(4).

• 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 ; +1(763)292-0920
• MDR Report Key: 50315445
• Report Number: 3006630150-2026-06043
• Device Sequence Number: 9882674
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: (01)08714729861638(17)190814(10)20984725
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/14/2019
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 20984725
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 08/14/2017
• 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: Male