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

Model Number	SC-2158-70
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in february 2022.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced inadequate stimulation and high impedance readings were discovered on the lead.Additionally, imaging that was taken confirmed that the lead had migrated.Reprogramming did not resolve the inadequate stimulation.Therefore, the patient underwent a lead revision procedure during which the lead was explanted and two new leads were implanted.The patient was doing well postoperatively.The explanted lead will not be returned as it was discarded by the medical facility.

• Brand Name: LINEAR
• 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 NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19586786
• Report Number: 3006630150-2024-03997
• Device Sequence Number: 14287972
• Product Code: LGW
• UDI-Device Identifier: 08714729767718
• UDI-Public: 08714729767718
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 06/30/2011
• Device Model Number: SC-2158-70
• Device Catalogue Number: SC-2158-70
• Device Lot Number: 247513
• 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: 06/14/2024
• Initial Report FDA Received Date: 06/21/2024
• 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 Sex: Unknown