• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INCORP. STIMWAVE PNS WIRELESS (STIMQ?) STIMULATOR PERIPHERAL NERVE, IMPLANTED PAIN RELIEF

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STIMWAVE TECHNOLOGIES INCORP. STIMWAVE PNS WIRELESS (STIMQ?) STIMULATOR PERIPHERAL NERVE, IMPLANTED PAIN RELIEF Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Burning Sensation (2146)
Event Date 01/21/2020
Event Type  Injury  
Event Description

New / worse symptoms; i have received the stimwave wireless pns on (b)(6) 2020 and after anesthesia and pain med wore off become extremely nauseous and vomiting. Rep did not hear of this before. Although online notes, could be caused by over stimulated nerves. Dr told to turn off on wednesday as rep thought it was anesthesia caused. Rep came thursday to reprogram to the lower voltage setting and sent down to program 1. Noticed during program 1, the pain that would normally radiate up to the head and eyeball region would stop at neck and create a new pain in middle of back below the pns implant. Next day - friday night was told to go back to program 2 and within 30 mins nausea and vomiting came back. Went to bed thinking it'll go away and didn't. Rep called again saturday morning and said that he should go back to program 1 at the highest setting and see if that gives enough relief for a permanent implant. Upon waiting until monday's appt to extract the temp leads, the shocking sensations increased and a burning sensation began that became to intense that had to turn off device. The rep appeared to care about the sale and not the actual fact that we should have stopped it at the first sign of nausea after reprogramming. Apparently the rep had never heard of the nausea / vomiting or the burning sensation of where lead placement was and as someone who works in the cro industry i feel that this is something that should be reported as this is a newer device to the market and all ae's should be reported as i feel the rep would not do this. Fda safety report id# (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTIMWAVE PNS WIRELESS (STIMQ?)
Type of DeviceSTIMULATOR PERIPHERAL NERVE, IMPLANTED PAIN RELIEF
Manufacturer (Section D)
STIMWAVE TECHNOLOGIES INCORP.
MDR Report Key9653796
MDR Text Key177571219
Report NumberMW5092666
Device Sequence Number1
Product Code GZF
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 01/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
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: 01/30/2020 Patient Sequence Number: 1
-
-