MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD STIMULATOR

Model Number	FR8A-TRL-B0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was implanted with a trial stimulators (fr8a-trl-a0 and fr8a-trl-b0) on (b)(6) 2017.The patient returned on (b)(6) 2017 for device removal (end of trial).Dr.(b)(6) was able to explant the a0 stimulator without issue.As dr.(b)(6) was removing the b0 trial stimulator, the device fractured at or around the marker band.In order to retrieve the stimulator, dr.(b)(6) advised that an incision would be required.The patient was uncomfortable with the retrieval procedure and requested that the stimulator not be removed until the permanent procedure.The patient did not experience injury, illness or infection.When explanting the b0 stimulator at the end of a trial, noticed that the stimulator was fracturing at or around the marker band.Based on this information, the fractured stimulator was confirmed/replicated, there is no evidence that product did not meet specification and the stimulator is used for treatment of pain.The cause of the fractured stimulator is unknown/no problem found.Device history record was reviewed and there were no non-conformances and product met specification at final release.This is the third reported case of lead fracture with stimwave stimulators.
Event or Problem Description
Stimwave quality has investigated the details surrounding a complaint resulting from an apparent stimulator fracture at the marker band with clinician and clinical specialist reported to stimwave on (b)(6) 2017.The stimulator was left in place at the patient's request.The stimulator will be explanted during the permanent procedure.This event did not result in any injury to the patient and therefore the clinician and specialist filed the official complaint later than the day of the incident.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10424437
• Report Number: 3010676138-2020-00105
• Device Sequence Number: 3672290
• Product Code: GZB
• UDI-Device Identifier: 00859619004929
• UDI-Public: 010085961900492917190301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

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: 03/01/2019
• Device Model Number: FR8A-TRL-B0
• Device Lot Number: SWO170302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention