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 Problems Erosion (1750); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, the patient visited the implanting clinician and reported pain at the implant site.The patient has a history of infection related to their previous implantable stimulator (different manufacturer).The implanting clinician decided to take blood tests.The results came back normal; however, the implanting clinician did not want to discard the possibility of an infection.The patient was sent home the same day without treatment and was instructed to follow up if the area was worse.The patient-maintained contact with the cr and was reprogrammed.On (b)(6) 2019, the implanting clinician contacted the cr to report the device was not providing therapy and was going to pull the trial stimulators due to a potential infection.Cultures were taken to determine if infection was present.On (b)(6) 2019, implanting clinician met with the patient and scheduled a revision for (b)(6) 2019.Infection culture results came back negative.The skin irritation was determined to be caused by the migration, making this an erosion.The patient is still using the stimulators and it is providing therapy.On (b)(6) 2020, the cr reported that the patient is doing well.The patient is currently working with three new programs.

Event Description

Stimwave quality has investigated the details for a reported skin irritation due to erosion (thought to be infection), submitted to the stimwave complaint system on (b)(6) 2019, by clinical representative (cr), in (b)(6).The exact awareness date of this issue is unknown.

• 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: 10330544
• MDR Text Key: 204387608
• Report Number: 3010676138-2020-00066
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• 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: SWO180206, SWO180215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention