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	High impedance (1291); Unexpected Therapeutic Results (1631); Charging Problem (2892); Impedance Problem (2950)
Health Effect - Clinical Codes	Headache (1880); Muscle Weakness/Atrophy (1967); Undesired Nerve Stimulation (1980); Pain (1994); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a car accident and was not getting adequate pain relief.It was also noted that the patient had undesired stimulation at the spine and had weakness whenever the stimulation was on.It was also reported that the patient had to charge the implantable pulse generator (ipg) more frequently after the accident.There were high impedances noted on the leads.While the rep was doing a reprogramming, the patient experienced headache.The patient underwent a spinal cord stimulator (scs) replacement procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in 2022.Additional suspect medical device components involved in the event: product family: scs-linear leads: upn: m365sc2317700, model: sc-2317-70, serial: (b)(6), batch: 20341430, udi: (b)(4).Product family: scs-linear leads: upn: m365sc2317700, model: sc-2317-70, serial: (b)(6), batch: 20341430, udi: (b)(4).
Event or Problem Description
It was reported that the patient had a car accident and was not getting adequate pain relief.It was also noted that the patient had undesired stimulation at the spine and had weakness whenever the stimulation was on.It was also reported that the patient had to charge the implantable pulse generator (ipg) more frequently after the accident.There were high impedances noted on the leads.The patient underwent a spinal cord stimulator (scs) replacement procedure and was doing well postoperatively.Additional information was received indicating that all explanted devices were discarded by the medical facility.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in 2022.Additional suspect medical device components involved in the event: product family: scs-linear leads.Upn: m365sc2317700.Model: sc-2317-70.Serial: (b)(6).Batch: 20341430.Udi: (b)(4).Product family: scs-linear leads.Upn: m365sc2317700.Model: sc-2317-70.Serial: (b)(6).Batch: 20341430.Udi: (b)(4).Investigation results: the device was discarded; therefore, a technical analysis could not be performed.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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established and known inherent risk of device.
Event or Problem Description
It was reported that the patient had a car accident and was not getting adequate pain relief.It was also noted that the patient had undesired stimulation at the spine and had weakness whenever the stimulation was on.It was also reported that the patient had to charge the implantable pulse generator (ipg) more frequently after the accident.There were high impedances noted on the leads.The patient underwent a spinal cord stimulator (scs) replacement procedure and was doing well postoperatively.Additional information was received indicating that all explanted devices were discarded by the medical facility.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 24199638
• Report Number: 3006630150-2026-00568
• Device Sequence Number: 9635895
• Product Code: LGW
• UDI-Device Identifier: 08714729953432
• UDI-Public: (01)08714729953432(17)190225(10)300133
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,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: 02/25/2019
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 20326225
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 04/20/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/31/2026; 05/11/2026
• Date Device Manufactured: 02/25/2017
• 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: 51 YR
• Patient Sex: Male