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 Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a spinal cord stimulation (scs) device underwent replacement of the implantable pulse generator (ipg) due to charging difficulties.The explanted ipg is unable to return.Following the replacement procedure, the patient recovered well postoperatively.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) confirmed that the device met specifications prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Block b3: estimated based on patient reports indicating difficulty with charging over the past couple of months.

• 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: 50841543
• Report Number: 3006630150-2026-06937
• Device Sequence Number: 18631311
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 10/13/2018
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 19830435
• 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: 07/22/2022
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 10/13/2016
• 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: 65 YR
• Patient Sex: Female