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

Model Number	SC-1132
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Battery Problem (2885)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing loss of stimulation.It was also noted that the patients implantable pulse generator (ipg) was nearing end of battery life.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted device was retained by customer per facility policy.
Additional Manufacturer Narrative
Block b3: exact date unknown, explant date used as the approximated date of 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50933398
• Report Number: 3006630150-2026-07196
• Device Sequence Number: 13449226
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 09/29/2026

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: 06/01/2015
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 16145338
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• 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: 62 YR
• Patient Sex: Female