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

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, a procedure was performed to implant one (1) stimq peripheral nerve stimulator (pns) system.Receiver (fr8a-rcv-a0) at the occipital nerve for head pain.The stimq pns system is not indicated for use at occipital.Nerves and was implanted off-label at the clinician's discretion.The territory manager confirmed that the implant.Procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.On (b)(6) 2019, the patient visited the implanting clinician's office for follow up and the implanting clinician observed that the stimulator was protruding through the skin.At the time of the event, the patient was still receiving therapy.The implanting clinician made the decision to explant the device as a precaution.The device was explanted the same day and no further complications were reported.Based on this information, the device erosion was confirmed/replicated, there is no evidence that product did not meet specification as this was used off label and the stimulator is used for treatment of pain.The cause of the device erosion is due to "off label use"-user error.Device history record was reviewed and there were no non-conformances and product met specification at final release.
Event or Problem Description
Stimwave quality has investigated the details regarding a complaint resulting from a device erosion through the skin reported to stimwave on july 10, 2019, by territory manager.

• 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: 10424448
• Report Number: 3010676138-2020-00115
• Device Sequence Number: 3672296
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: 010085961900487517190801
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/26/2020

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: 08/01/2019
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO170828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• 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