MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0,ST4-SPR-B0

Device Problem Migration (4003)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache, Lumbar Puncture (2186)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Immediately following notification, stimwave quality and the territory manager reviewed events preceding the issue.The patient had a permanent procedure performed on (b)(6) 2019, in which one (1) stimq receiver stimulator (stq4-rcv-a0) and one (1) spare lead (stq4-spr-b0) were implanted bilaterally at the l1 vertebral level.The territory manager confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.The procedure was completed without complication, and the territory manager maintained contact with the patient following implant.On october 8, 2019, the patient reported to the implanting clinician they were experiencing positional headaches.The patient was admitted on (b)(6) 2019 and was treated with blood patches.The patient went home the same day without further complications.The implanting clinician was concerned the device had migrated and performed imaging tests.The images confirmed the device had migrated and scheduled the patient for a revision procedure.On (b)(6) 2019, the patient visited the implanting clinician's office for a revision.The territory manager was contacted on this date and attended the revision procedure.During the explant procedure, the implanting clinician and the territory manager observed the device had migrated further into the epidural space and had punctured the dura mater and there was cerebrospinal fluid leakage.The implanting clinician made the decision the remove the devices and provided an epidural blood patch at the affected location.The patient reported to be getting therapy from the device up until the moment of explant.The implanting clinician believes the issue is attributed to patient physiology or unknown patient comorbidities.The territory manager and the implanting clinician confirmed the devices were implanted according to the instructions for use and implant steps to mitigate migration were followed.Migration is a known adverse event for peripheral nerve stimulation and the stimq pns system, and is detailed in stimwave's risk management file as well as applicable instruction for use and patient-facing labeling.Stimwave's global migration rate is (b)(6).The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, or nonconformance to physical or functional device specifications.The stimwave product was not the source of the issue.The root cause is attributed to the patient's physiology or unknown comorbidities.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Stimwave has confirmed that the issue is a known adverse event, mitigated as far as possible, and documented in the stimwave risk management file.Stimwave was in constant contact with the territory manager from october 22, 2019, onward regarding the complaint and the root cause investigation.Stimwave confirmed that the implant procedure details steps to mitigate migration, and that the product did not fail to meet performance and safety specifications.The source of the issue is attributed to patient physiology or unknown comorbidities.Stimwave has informed all parties that the product was not the source issue.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this issue is considered reportable as this event required medical intervention by a health care professional to prevent or preclude potential permanent impairment or damage.Stimwave reported this issue to the united states food and drug administration (fda) on november 13, 2019.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from device migration reported to stimwave on (b)(6) 2019, by territory manager.

• Brand Name: STIMQ PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: elizabeth greene ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 9318767
• MDR Text Key: 185506206
• Report Number: 3010676138-2019-00047
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)210401(01)00818225020495(17)210401(21)201263-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2021
• Device Model Number: STQ4-RCV-A0,ST4-SPR-B0
• Device Lot Number: SWO190414, SWO190423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2019
• 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