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

Model Number FR8A-TRL-A0, FR8A-TRL-B0

Device Problem Migration (4003)

Patient Problems Erosion (1750); Skin Irritation (2076)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, the pre-scheduled stimulator pull, it was discovered that the trial stimulator had migrated downward from top of 8th thoracic vertebrae to the top of 5th thoracic vertebrae.The implanting clinician had to perform an incision to obtain the tail end of the stimulator to pull it out.The implanting clinician took cultures of the wound (as the incision was red and irritated) after successfully removing the trial stimulator.On (b)(6) 2020, the patient had a follow-up appointment with the implanting clinician.During this follow-up, the cultures were received and no infection was present.The cr followed up with patient and the patient stated that is doing well and is not reporting irritation or further issues after the removal of the trial leads.The patient is planning to move forward with a permanent implant procedure.On (b)(6), 2020, the cr reported that the implanting clinician was not compliant with the ifu (document # 05-00347, revision 14, page 22, section: securing the trial lead).The implanting clinician reported using mastisol and steristrips to secure the stimulators.

Event Description

Stimwave quality has investigated the details for a reported migration/skin irritation, 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: 10172077
• MDR Text Key: 201006981
• Report Number: 3010676138-2020-00044
• 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: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2021
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO200227, SWO190614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• 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
• Patient Age: 57 YR