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

Model Number FR8-RCV-A0, FR8-SPR-B0

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

On the questionnaire dated april 8, 2020, the clinical representative reported that the patient has received excellent pain relief from her spinal cord stimulator (fr8a-rcv-a0) implanted in the epidural space of the cervical region on the spine.On (b)(6) 2020, the patient had a return of the peripheral pain in the middle of her back, near the location of the fr8a-spr-b0 stimulator.The patient reported feeling something "pop" prior to the loss of therapy.This "pop" was believed to have been the anchoring stitch.The patient met with the implanting clinician for an x-ray.The x-ray confirmed stimulator (fr8a-spr-b0) caudal (towards the posterior) migration of approximately 15cm.This stimulator (fr8a-spr-b0) was implanted off-label, in the mid back outside of the epidural space as a peripheral nerve stimulator (pns).The implanting clinician has been granted tga special access for a tined stimq stimulators to perform a revision scheduled for (b)(6) 2020.The root cause of this migration is due to the spinal cord stimulator (fr8a-spr-b0) being implanted off-label outside of the epidural space of the spine, causing inability to appropriately anchor the stimulator to prevent migration.

Event Description

On (b)(6) 2020, the patient had a return of the peripheral pain in the middle of her back, near the location of the fr8a-spr-b0 stimulator.The patient reported feeling something "pop" prior to the loss of therapy.This "pop" was believed to have been the anchoring stitch.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• 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: 10022943
• MDR Text Key: 197007373
• Report Number: 3010676138-2020-00042
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: FR8-RCV-A0, FR8-SPR-B0
• Device Lot Number: SWO171024,SWO171206
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• 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