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

Model Number FR8A-RCV-A0, FR8A-TRL-A0

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the territory manager reviewed the events.On (b)(6) 2019, the patient had a trial procedure performed in which one (1) freedom-8a trial lead (fr8a-trl-a0) was implanted at the occipital nerve.This is an off-label use of the stimq peripheral nerve stimulator (pns) system, which excludes craniofacial nerves.The implanting clinician was aware of the off-label indication, but performed the procedure at his discretion as a medical professional, which is his option but is not a cleared fda indication for the stimq pns system.Nine (9) days following the trial procedure, the patient reported that the device was protruding out of the skin.The implanting clinician's notes reported that "the patient was feeling so well and was able to play with their knees, and unfortunately the lead got pulled out without any bleeding or pain." further review of the patient's post-implant course demonstrated that the device protruded when the patient was participating in strenuous activity and was inadvertently pulled out by the patient's grandson.The patient visited the implanting clinician at the time of the event (exact date is unknown) and the wound was treated.The territory manager at the time of the event reported that the patient's wound was clean and there were no signs of infection.There were no allegations against the device performance at the time of the event; the patient did not report loss of therapy at any point during the trial.Based on this information, the device erosion was confirmed/replicated, there is no evidence that product did not meet specification and the cause of the device erosion is patient non-compliance.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 an alleged trial and permanent device erosion reported to stimwave on (b)(6) 2019 through a letter received from the better business bureau.

• 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: 10425847
• MDR Text Key: 212442063
• Report Number: 3010676138-2020-00122
• Device Sequence Number: 1
• Product Code: GZB
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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, FR8A-TRL-A0
• Device Lot Number: SWO170828, SWO180404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2019
• 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