MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Avista? MRI; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-2408-74
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event:\ model number/catalog number: sc-2408-74.\ serial number: (b)(6).\ batch/lot number: 20460191.\ model/catalog description: avista mri perc lead kit 74 cm.\ unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the leads had high impedances.The patient underwent a lead replacement procedure.Patient for coverage of pain area in recovery.

• Brand Name: Avista? MRI
• 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 sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50037763
• Report Number: 3006630150-2026-05319
• Device Sequence Number: 10421130
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: (01)08714729904823(17)190331(10)20460191
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 03/31/2019
• Device Model Number: SC-2408-74
• Device Catalogue Number: SC-2408-74
• Device Lot Number: 20460191
• 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: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 03/31/2017
• 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: 79 YR
• Patient Sex: Female