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

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).

• Brand Name: STIMWAVE PNS WIRELESS (STIMQ?)
• Type of Device: STIMULATOR PERIPHERAL NERVE, IMPLANTED PAIN RELIEF
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INCORP.
• MDR Report Key: 9653796
• MDR Text Key: 177571219
• Report Number: MW5092666
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 92