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

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

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Complaint-(b)(4)was reported to stimwave on october 2, 2019, and verified to be the same stimulator complaint through comparing stimulator serial number sections on issue-1507 (complaint-(b)(4)) and issue-253 (complaint-(b)(4)).Complaint-(b)(4)was captured in capa-(b)(4) as being reportable and requiring remediation.In complaint-(b)(4), the patient reported the same skin irritation caused by migration.At that time, no intervention was required, although the migration causing skin irritation does run the risk of erosion leading to potential infection.On (b)(6) 2020, the patient contacted the cr reporting that one of stimulators has migrated and is now visibly seen under the skin near the patient's groin.The patient was unable to provide any further information about the issue as she was not able to go to a hospital due to the covid-19 restrictions.On (b)(6) 2020, the cr reported that the patient still has both stimulators implanted and is scheduled for an appointment with the implanting clinician to discuss doing and explant.Patient mentioned that she was not having great therapy since the migration occurred.Patient does continue to activate the stimulators for intermittent relief after high activity.On (b)(6) 2020, the cr reported that it was unknown which of the two fr8a stimulators had migrated.Cr also reported that patient had been active prior to and post migration issue.On (b)(6) 2020, the cr reported that the patient had a revision done on the stimulator that had migrated.The cr reported that the patient was not reprogrammed and was doing well post revision.No further issues have been reported.

Event Description

Stimwave quality has investigated the details for a reported skin irritation caused by migration, submitted to the stimwave complaint system on (b)(6) 2020, by clinical representative (cr), in (b)(6).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: 10160228
• MDR Text Key: 196152845
• Report Number: 3010676138-2020-00053
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2020
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO171024, SWO180215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR