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

Model Number	FR4A-TRL-B0
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting an expired device, not prepping the skin, and using inappropriate tools have been ruled out as potential causes.The implanting clinician stated that the cause of the infection was unknown.However, the questionnaire shows, the clinical representative is unsure if antibiotics were prescribed pre-operatively and if the site was irrigated before closure which are potentially contributing causes for the occurrence.The clinical representative confirmed the patient did not have pre-existing conditions.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 the infection likely due antibiotics not being prescribed pre-operatively and the site was not irrigated before closure (user error-clinician).
Event or Problem Description
The patient reported an infection in their ankle and leg following a trial.The lead was removed on (b)(6) 2021.No further issues were reported.

• 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: 12485700
• Report Number: 3010676138-2021-00195
• Device Sequence Number: 4081573
• Product Code: GZF
• UDI-Device Identifier: 00818225020709
• UDI-Public: 010081822502070917221201
• 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): 09/14/2021

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: 12/01/2022
• Device Model Number: FR4A-TRL-B0
• Device Lot Number: SWO201228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/16/2021
• 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