MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION PRECISION SPECTRA?; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-1032B
Medical Device Problem Codes	High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event additional suspect medical device components involved in the event: product family: scs-linear leads upn: m365sc2218500, model: sc-2218-50, serial: (b)(6), batch: 17186032, udi: (b)(4).
Event or Problem Description
It was reported that these spinal cord stimulation (scs) devices were replaced due to an unknown reason.The location of the devices is unknown.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that these spinal cord stimulation (scs) devices were replaced due to an unknown reason.The location of the devices is unknown.No additional adverse patient effects were reported.Additional information was received stating that the scs implantable pulse generator (ipg) was replaced due to high impedances.The lead was replaced so the patient could be magnetic resonance imaging (mri) compatible.The devices were retained by the facility and will not be returned for analysis.Postoperatively, the patient was doing fine.
Additional Manufacturer Narrative
The correct aware date of the initial report should have been 01/10/2023.B3: approximated based on the date the manufacturer became aware of the event additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2218500.Model: sc-2218-50.Serial: (b)(6).Batch: 17186032.Udi: (b)(4).
Additional Manufacturer Narrative
Correction to the supplemental mdr in h6.The correct aware date of the initial report should have been 01/10/2023.B3: approximated based on the date the manufacturer became aware of the event additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500.Model: sc-2218-50.Serial: (b)(6).Batch: 17186032.Udi: (b)(4).
Event or Problem Description
It was reported that these spinal cord stimulation (scs) devices were replaced due to an unknown reason.The location of the devices is unknown.No additional adverse patient effects were reported.Additional information was received stating that the scs implantable pulse generator (ipg) was replaced due to high impedances.The lead was replaced so the patient could be magnetic resonance imaging (mri) compatible.The devices were retained by the facility and will not be returned for analysis.Postoperatively, the patient was doing fine.

• Brand Name: PRECISION SPECTRA?
• 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 ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23022146
• Report Number: 3006630150-2025-07457
• Device Sequence Number: 15830733
• Product Code: LGW
• UDI-Device Identifier: 08714729861539
• UDI-Public: (01)08714729861539(17)170610(10)131129
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/19/2026

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: 06/10/2017
• Device Model Number: SC-1032B
• Device Catalogue Number: SC-1032B
• Device Lot Number: 131129
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 01/13/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/27/2025; 01/19/2026
• Date Device Manufactured: 06/11/2015
• 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: 44 YR
• Patient Sex: Female