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

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On may 7, 2019, the territory manager was made aware that a patient's incision site had opened, and an x-ray revealed fluid at the distal end of the implant.The implanting clinician informed the territory manager that the patient reported good pain relief with the device.As a precaution, the implanting clinician prescribed oral antibiotic (keflex 500mg, taken 4 times a day, duration unknown) and the patient was sent home.The patient reported no other issues with the system before, during, or after the permanent procedure.Based on this information, the wound not healing was confirmed/replicated, there is no evidence that product did not meet specification and the stimulator is used for treatment of pain.The cause of the wound not healing is unknown/no problem found.Device history record was reviewed and there were no non-conformances and product met specification at final release.
Event or Problem Description
Stimwave quality has investigated the details surrounding a complaint resulting from an unconfirmed infection that occurred in (b)(6) reported to stimwave on may 7, 2019, by stimwave territory manager.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10424434
• Report Number: 3010676138-2020-00109
• Device Sequence Number: 14370576
• Product Code: GZB
• UDI-Device Identifier: 00818225020792
• UDI-Public: 010081822502079217200201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/26/2020

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: 02/01/2018
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO180206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 08/19/2020
• 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