MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD NERVE STIMULATOR

Model Number	FR8A-SPR-B0
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was prescribed an additional round of antibiotics, the implanting clinician decided not to perform and revision/explant, and the patient is currently doing well.No further issues have been reported.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile, implanting an expired device, not irrigating the incision site, the patient picking at the wound, the patient having pre-existing conditions, not using antibiotics, not prepping the skin, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.The implanting clinician stated that the cause of the infection was unknown.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 fluid at the incision site is infection.However, the cause of the infection is no problem/fault found.
Event or Problem Description
Patient had fluid coming from spinal cord implant incision site.As a result, the doctor prescribed another week of antibiotics.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINAL CORD NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 12368390
• Report Number: 3010676138-2021-00181
• Device Sequence Number: 3887351
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817230501
• 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
• 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): 08/22/2021

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: 05/01/2023
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: WO210520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: Other