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U.S. Department of Health and Human Services

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

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STIMWAVE TECHNOLOGIES INCORPORATED WORN OFF (UNPROTECTED)STIMWAVE FREEDOM SPINAL NERVE STIMULATOR STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
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).

 
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Brand NameWORN OFF (UNPROTECTED)STIMWAVE FREEDOM SPINAL NERVE STIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Manufacturer (Section D)
STIMWAVE TECHNOLOGIES INCORPORATED
MDR Report Key11348162
MDR Text Key232886728
Report NumberMW5099487
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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 Received02/18/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberFREEDOM WAA
Device LOT NumberWORN OFF (UNPROTECTED)
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/18/2021 Patient Sequence Number: 1
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