MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION INFINION? 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2316-70
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients leads had migrated.It was stated that the patient was experiencing firing to the upper arm and leg and currently, the implantable pulse generator (ipg) was turned off.It was also stated that the patient was programmed prior to surgery and received adequate coverage.The patient underwent a revision procedure wherein the lead, splitter and ipg were replaced.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in 2018.Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2218500, model: sc-2218-50, serial: (b)(6), batch: 17718321.Product family: scs-linear leads: upn: m365sc2218700, model: sc-2218-70, serial: (b)(6), batch: 17613429.Product family: scs-ipg-r: upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: 16309193.
Event or Problem Description
It was reported that the patients leads had migrated.It was stated that the patient was experiencing firing to the upper arm and leg and currently, the implantable pulse generator (ipg) was turned off.It was also stated that the patient was programmed prior to surgery and received adequate coverage.The patient underwent a revision procedure wherein the lead, splitter and ipg were replaced.Additional information was received that the patient was doing well postoperatively and the explanted devices were discarded by the medical facility.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks b5 and h6.
Event or Problem Description
It was reported that the patients lead had migrated, confirmed by x ray.It was stated that the patient was experiencing firing to the upper arm and leg and currently the implantable pulse generator (ipg) was turned off.It was also stated that the patient was programmed prior to surgery and received adequate coverage.The patient underwent a revision procedure wherein the lead was replaced.Additional information was received that the patient was doing well postoperatively and the explanted devices were discarded by the medical facility.
Event or Problem Description
It was reported that the patients lead had migrated, confirmed by x ray.It was stated that the patient was experiencing firing to the upper arm and leg and currently the implantable pulse generator (ipg) was turned off.It was also stated that the patient was programmed prior to surgery and received adequate coverage.The patient underwent a revision procedure wherein the lead was replaced.Additional information was received that the patient was doing well postoperatively and the explanted devices were discarded by the medical facility.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks b5 and h6.Investigation results: 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.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 all available information, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: INFINION? 16
• 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: 20477863
• Report Number: 3006630150-2024-07080
• Device Sequence Number: 12863510
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/03/2015
• Device Model Number: SC-2316-70
• Device Catalogue Number: SC-2316-70
• Device Lot Number: 16338677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 04/14/2026; 05/25/2026
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/09/2024; 04/23/2026; 06/19/2026
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 140 LB