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

Model Number FR8A-RCV-A0, STQ4-SPR-B0

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Following the notification, stimwave quality and the cr reviewed the events preceding this issue.The patient had one freedom-8a neurostimulator implanted, off-label, and the left superior cluneal nerve and one stim-q neurostimulator implanted, at the left medial cluneal nerves for pain on (b)(6) 2019.On (b)(6)2020, the implanting clinician reported surgically explanting both stimulators due to the patient experiencing a suture erosion and skin irritation.On (b)(6) 2020, cr reported that the that patient had an unusual configuration of neurostimulators due to existing lower spine hardware.On (b)(6) 2020, cr reported that patient was healing well after the explant.Patient is also interested in continuing use of neurostimulators.Implanting clinician recommended waiting until patient's incisions healed.Cr was suggested to have implanting clinician contact chief medical officer about a technique for future implant.The stimulator was reported to meet product specifications.Device can not currently be received by manufacturer for analysis.The device was used for treatment of pain.

Event Description

Stimwave quality has investigated the details for a reported erosion, submitted to the stimwave complaint system on (b)(6) 2020, by clinical representative (cr), in the united states.Cr became aware of this issue (b)(6) 2020.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10210407
• MDR Text Key: 202860469
• Report Number: 3010676138-2020-00064
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/23/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Model Number: FR8A-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO190701, SWO190424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention