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

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

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, during the implant procedure, the first two stimulators were compromised when sandshark anchoring system was being deployed.The fr8a-spr-b0 was fully retrieved, however, the fr8a-rcv-a0 stimulator was fractured.The fractured stimulator is free-floating in the epidural space with a steering stylet.The patient is not mri compatible due to this fractured stimulator.After this surgical complication, the implanting clinician placed two new freedom-8a neurostimulators into the same location, successfully deploying the sandshark anchoring system.Patient confirmed therapy with the new neurostimulators and is recovering from surgery.No further complications were reported.The stimulators were reported to meet product specifications.Device can not currently be received by manufacturer for analysis.The device was used for treatment of pain.

Event Description

Stimwave quality has investigated the details regarding a complaint of fractured stimulator reported to stimwave's complaint system on (b)(6) 2020, by clinical representative, in the united states.Stimwave became aware of the issue on april 23, 2020.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach 33064
• MDR Report Key: 10670053
• MDR Text Key: 216577364
• Report Number: 3010676138-2020-00071
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO191103, SWO180815
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• 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
• Patient Age: 59 YR