MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INCORPORATED STIMWAVE FREEDOM SPINAL NERVE STIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number FREEDOM WAA

Device Problems Failure to Charge (1085); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

I had the leads for a stimwave freedom sns implanted (b)(6).It was about 10 weeks before i got the controllers.In the time since then, i believe 4 of the devices have failed completely, and now one of the 2 i have won't charge completely.I don't believe the rep is reporting the failures to the fda.The company has no way to give consumer feedback.These things are garbage and should have never been approved.Stimwave freedom sns meds are irrelevant and too many to list.Fda safety report id# (b)(4).

• Brand Name: STIMWAVE FREEDOM SPINAL NERVE STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INCORPORATED
• MDR Report Key: 11348162
• MDR Text Key: 232886728
• Report Number: MW5099487
• Device Sequence Number: 4
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/16/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FREEDOM WAA
• Device Lot Number: WORN OFF (UNPROTECTED)
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 45 YR
• Patient Weight: 102