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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event additional suspect medical device components involved in the event: model number/catalog number: sc-2352-50 serial number: (b)(6) batch/lot number: 14822308 model/catalog description: linear 3-4 lead 50 cm unique identifier (udi):(b)(4) additional suspect medical device components involved in the event: model number/catalog number: sc-2352-50 serial number: 422333 batch/lot number: 14822308 model/catalog description: linear 3-4 lead 50 cm unique identifier (udi): (b)(4) additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50 serial number: (b)(6) batch/lot number: 5038916 model/catalog description: linear st lead kit 50 cm unique identifier (udi): (b)(4) additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50 serial number: (b)(6) batch/lot number: 5038432 model/catalog description: linear st lead kit 50 cm unique identifier (udi): (b)(4).
Event or Problem Description
It was reported that this spinal cord stimulation (scs) system was explanted due to an unknown reason.The location of the devices is unknown.No additional adverse patient effects were reported.No additional information is available at this time.
Event or Problem Description
It was reported that this spinal cord stimulation (scs) system was explanted due to an unknown reason.The location of the devices is unknown.No additional adverse patient effects were reported.No additional information is available at this time.
Additional Manufacturer Narrative
Correction: block d1 was updated to reflect most accurate information related to this event.The devices were not returned to boston scientific for analysis, and the complaint as reported could not be confirmed.A review of the devices history record (dhr) confirmed that the devices met specifications prior to shipping.No manufacturing deviations were identified that could have contributed to the reported event.Therefore, in the absence of devices return and analysis the likely root cause could not be established.Block b3: approximated based on the date the manufacturer became aware of the event additional suspect medical device components involved in the event: model number/catalog number: sc-2352-50 serial number: (b)(6) batch/lot number: 14822308 model/catalog description: linear 3-4 lead 50 cm unique identifier (udi): (b)(4) additional suspect medical device components involved in the event: model number/catalog number: sc-2352-50 serial number: (b)(6) batch/lot number: 14822308 model/catalog description: linear 3-4 lead 50 cm unique identifier (udi): (b)(4) additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50 serial number: (b)(6) batch/lot number: 5038916 model/catalog description: linear st lead kit 50 cm unique identifier (udi): (b)(4) additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50 serial number: (b)(6) batch/lot number: 5038432 model/catalog description: linear st lead kit 50 cm unique identifier (udi): (b)(4).

• 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: 25333490
• Report Number: 3006630150-2026-03612
• Device Sequence Number: 13226883
• Product Code: LGW
• UDI-Device Identifier: 08714729861539
• UDI-Public: (01)08714729861539(17)180518(10)146865
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: 05/18/2018
• Device Model Number: SC-1032B
• Device Catalogue Number: SC-1032B
• Device Lot Number: 146865
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/16/2026
• Date Device Manufactured: 05/18/2016
• 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: 61 YR
• Patient Sex: Female