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

Model Number	FR4A-RCV-A0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2020, the cr became involved in this complaint by receiving an e-mail asking for field support help in (b)(6).The e-mail stated a patient was experiencing a 30-40% reduction in pain relief, outlining that the cause of the issue was unknown.On (b)(6), 2020, the implanting clinician met with the patient to follow up on the loss of therapy.The implanting clinician discovered the lead was eroding since the stimulator had migrated, and a revision or replacement needed to be scheduled.This information was related to the cr via e-mail on june 9, 2020.On july 14, 2020, the implanting clinician e-mailed the cr advising that a revision was scheduled to be performed on (b)(6) 2020.The implanting clinician removed stimulator, and two freedom-4a neurostimulators were implanted at the tibial and sural nerves for leg pain.The cr confirmed that the revision procedure was performed in a sterile environment, sterile field handling protocols were used, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication.On (b)(6) 2020, the implanting clinician confirmed that the patient is receiving paresthesia from the stimulator and has helped with pain relief.On (b)(6) 2020, the cr confirmed that the patient did not experience an infection after the stimulator's erosion, and the patient was not prescribed antibiotics.The cr also noted the reason for the erosion was unknown to the patient and the implanting clinician.The stimulator was reported to meet product specifications.Manufacturer cannot currently receive the stimulator for analysis.The device was used for treatment of pain.The device cannot be traced as the source of the issue.
Event or Problem Description
Stimwave quality has investigated the details for a reported erosion submitted to the stimwave complaint system on july 14, 2020, by clinical representatives (cr), in (b)(6).Cr became aware of this issue june 4, 2020.

• 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: 10389076
• Report Number: 3010676138-2020-00074
• Device Sequence Number: 19557900
• Product Code: GZB
• UDI-Device Identifier: 00818225020617
• UDI-Public: 010081822502061717210701
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: 07/01/2021
• Device Model Number: FR4A-RCV-A0
• Device Lot Number: SWO190701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/10/2020
• 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