MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ NEUROSTIMULATOR; PERIPHERAL NERVE STIMULATOR

Model Number	FR41-TRL-B0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stimulator was explanted on (b)(6) 2021, and disposed of on-site.No complications or infection was evident or anticipated.Patient-reported receiving effective therapy before the end of the trial period when the device was explanted.The stimwave quality director interviewed the clinical representative.During the interview, the following information was learned: the clinical representative did not notice the expiration date.The surgical issue questionnaire was not reviewed since the complaint was submitted by stimwave quality, and the questions were answered based on the ifu.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of implanting an expired product is user error- clinical representative due to not adhering to product handling and ordering procedure 50-128 rev 4.
Event or Problem Description
The device was implanted after the device's expiration date.

• Brand Name: STIMQ NEUROSTIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 12257341
• Report Number: 3010676138-2021-00162
• Device Sequence Number: 17309438
• Product Code: GZF
• UDI-Device Identifier: 00818225020587
• UDI-Public: 010081822502058717210201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: FR41-TRL-B0
• Device Lot Number: SWO190227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 08/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention