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

Model Number	SC-1060B
Medical Device Problem Codes	Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this spinal cord stimulation (scs) system was replaced due to an unknown reason.The location of the devices is unknown.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-ipg-r, upn: m365sc1060b0, model: sc-1060b, serial: (b)(6), batch: 343696.
Additional Manufacturer Narrative
Supplemental submitted to include additional information received from boston scientific sales representative that changed fields b5 and f10.Product family: scs-ipg-r; upn: m365sc1060b0; model: sc-1060b; serial: (b)(6), batch: 343696.
Event or Problem Description
It was reported that this spinal cord stimulation (scs) system was replaced due to an increased charging burden of the implantable pulse generator (ipg) as well as a decrease in efficacy of therapy when the battery was low.The patient is getting good pain relief post operatively.Device will not return due to facility policy and electrocautery was not used near new ipg.

• Brand Name: SPECTRA WAVEWRITER
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 20083108
• Report Number: 3006630150-2024-05666
• Device Sequence Number: 18042167
• Product Code: LGW
• UDI-Device Identifier: 08714729953432
• UDI-Public: 08714729953432
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2024
• 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): 09/26/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/05/2020
• Device Model Number: SC-1060B
• Device Catalogue Number: SC-1060B
• Device Lot Number: 343696
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/27/2024
• Date Device Manufactured: 09/06/2018
• 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 Sex: Unknown