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	Fracture (1260); High impedance (1291); Charging Problem (2892); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patients leads had fractured, which was confirmed through x-ray.No further information could be obtained.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-linear leads upn:m365sc2316700, model:sc-2316-70, serial: (b)(6), batch:7016427.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-ipg-r, upn: m365sc11600, model: sc-1160, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: scs-splitters, upn: m365sc3400300, model: sc-3400-30, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: scs-splitters, upn: m365sc3400300, model: sc-3400-30, serial: (b)(6), batch: (b)(6), udi: (b)(4).
Event or Problem Description
It was reported that the patients leads had fractured, which was confirmed through x-ray.No further information could be obtained.Additional information was received that the patients lead broke and left contacts in the upper space.It was also mentioned that the implantable pulse generator (ipg) was not holding a charge.The patient underwent a procedure wherein the ipg and leads were replaced.The patient was doing well postoperatively, and the explanted devices were not returned due to hospital policy.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21340764
• Report Number: 3006630150-2025-00572
• Device Sequence Number: 8432042
• Product Code: LGW
• UDI-Device Identifier: 08714729797821
• UDI-Public: (01)08714729797821(17)200207(10)5027809(21)5027809
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 02/07/2020
• Device Model Number: SC-2316-70
• Device Catalogue Number: SC-2316-70
• Device Lot Number: 5027809
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 02/09/2025
• Supplement Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 02/07/2018
• 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: 41 YR
• Patient Sex: Female