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

Model Number FR8A-RCV-A0

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Following the notification, stimwave quality and the crs reviewed the events preceding this issue.The patient had one freedom-8a neurostimulator implanted, off-label, at the ear tunneled to the supra orbital nerve (near the eye brow) on november 25, 2019.On july, 16, 2020, cr reported that the event was a complication during surgery.Implanting clinician perforated the patient's forehead with needle.Implanting clinician did not become aware of this after the operation.Cr reported that the implanting clinician tried to remedy the situation, but was unsuccessful as the neurostimulators eroded.Cr reported patient had a revision on an unknown date.Cr reported losing contact with the patient after relocation.On august 10, 2020, complaint specialist, reviewed sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of loss of therapy is evident for swo190815, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator was reported to meet product specifications.Manufacturer cannot currently receive the stimulator for analysis.The device was used for treatment of pain.The device cannot be traced as the source of the issue.

Event Description

Stimwave quality has investigated the details for a report of tissue damage/erosion submitted to the stimwave complaint system on december 10, 2019, by clinical representatives (cr), in the united states.Crs became aware of this issue on an unknown date.

• 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: 10419595
• MDR Text Key: 203860915
• Report Number: 3010676138-2020-00096
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: 010081822502069317210801
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO190815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2019
• 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