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U.S. Department of Health and Human Services

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

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STIMWAVE TECHNOLOGIES INCORPORATED STIMWAVE FREEDOM STIMULATORS STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Device Problems Failure to Charge (1085); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2020
Event Type  Malfunction  
Event Description

Stimwave battery doesn't hold a charge, supposed to last 12 hours. The stim/wave wearable pad stopped working, carries stimulate to nerves via implanted stimwave implants. Fda safety report id# (b)(4).

 
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Brand NameSTIMWAVE FREEDOM STIMULATORS
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Manufacturer (Section D)
STIMWAVE TECHNOLOGIES INCORPORATED
MDR Report Key9823644
MDR Text Key183352283
Report NumberMW5093691
Device Sequence Number1
Product Code GZB
Combination Product (Y/N)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 03/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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

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