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	Nonstandard Device (1420); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's implantable pulse generator (ipg) had stopped working after a fall.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg was retained by the medical facility and will not be returned.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred three weeks prior to the date the manufacturer became aware of the event.

• 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: 25031375
• Report Number: 3006630150-2026-02742
• Device Sequence Number: 10186121
• Product Code: LGW
• UDI-Device Identifier: 08714729861539
• UDI-Public: (01)08714729861539(17)190313(10)160599
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• 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
• 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: 03/13/2019
• Device Model Number: SC-1032B
• Device Catalogue Number: SC-1032B
• Device Lot Number: 160599
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 07/16/2026
• Date Device Manufactured: 03/13/2017
• 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: 54 YR
• Patient Sex: Male