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

Model Number	SC-1160
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Charging Problem (2892); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients implantable pulse generator (ipg) had difficulty communicating with the remote control.It was also noted that the ipg would not hold a charge.The patient underwent an ipg replacement procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks b5 and h6.
Event or Problem Description
It was reported that the patient underwent an implantable pulse generator (ipg) replacement procedure due to charging difficulty and communication issues.Troubleshooting was performed but was not successful.The patient experienced a loss of stimulation as a result of the ipg no longer functioning.The patient is doing well postoperatively after the explant procedure.The explanted device will not be returned.
Event or Problem Description
It was reported that the patient underwent an implantable pulse generator (ipg) replacement procedure due to charging difficulty and communication issues.Troubleshooting was performed but was not successful.The patient experienced a loss of stimulation as a result of the ipg no longer functioning.The patient is doing well postoperatively after the explant procedure.The explanted device will not be returned.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks b5 and h6.Investigation results the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however response was not received.Device history record it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: SPECTRA WAVEWRITER?
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 20457080
• Report Number: 3006630150-2024-06979
• Device Sequence Number: 8856102
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: 01/07/2021
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 348201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 04/12/2026; 04/16/2026
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 04/16/2026; 05/11/2026
• Date Device Manufactured: 01/08/2019
• 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: 75 YR
• Patient Sex: Male