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

Model Number	SC-2316-70
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2316700.Model: sc-2316-70.Serial: (b)(6).Batch: 21246581.Product family: scs-splitters.Upn: m365sc3400300.Model: sc-3400-30.Serial: (b)(6).Batch: 20441565.Product family: scs-splitters.Upn: m365sc3400300.Model: sc-3400-30.Serial: (b)(6).Batch: 20441565.
Event or Problem Description
It was reported that during a programming session, high impedances measurements were discovered on the spinal cord stimulation (scs) patient's leads.Despite programming having successfully covered all pain areas using the unaffected contacts, the patient underwent a revision procedure wherein the leads were replaced, and the splitters removed.The patient did well postoperatively.The explanted devices were disposed of by the medical facility.

• Brand Name: INFINION 16
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 20152340
• Report Number: 3006630150-2024-05904
• Device Sequence Number: 15552946
• Product Code: LGW
• UDI-Device Identifier: 08714729797821
• UDI-Public: 08714729797821
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: 07/12/2019
• Device Model Number: SC-2316-70
• Device Catalogue Number: SC-2316-70
• Device Lot Number: 20865432
• 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: 08/12/2024
• Initial Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 07/12/2017
• 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: 58 YR
• Patient Sex: Female