MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2366-50
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 7070012.Product family: scs-linear leads.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 7070590.Product family: scs-linear leads.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 7071790.Product family: scs-ipg-r.Upn: m365sc11600.Model: sc-1160.Serial: (b)(6).Batch: sc-1160.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced sensitivity and discomfort at one of her two implantable pulse generator (ipg) pocket sites and underwent a revision procedure (reported in mfr# 3006630150-2024-08047).During the procedure it was found that the leads from both systems had become entangled.As a result, the leads were removed; and due to the fact that the physician felt that therapy needs could be accomplished with one system the ipg was also removed.The patient did well postoperatively.It was noted that the patient wore a compressive girdle, and the act of putting it on and wearing it the full day appeared to have pushed down on the ipg which may have caused the devices to move.

• Brand Name: LINEAR 3-6
• 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: 20755115
• Report Number: 3006630150-2024-08048
• Device Sequence Number: 18282994
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: 08714729789574
• 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: 2020
• 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): 11/21/2024

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: 07/13/2022
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 7071973
• 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: 11/06/2024
• Initial Report FDA Received Date: 11/22/2024
• Date Device Manufactured: 07/13/2020
• 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: 82 YR
• Patient Sex: Female