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

Model Number FR8A-RCV-A0

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Date 05/30/2019

Event Type  Injury  

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 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
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10424448
• MDR Text Key: 203705234
• Report Number: 3010676138-2020-00115
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: 010085961900487517190801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention