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

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

Device Problems Migration (4003); Unintended Electrical Shock (4018)

Patient Problems Erosion (1750); Shock from Patient Lead(s) (3162)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020, the patient contacted the cr reported that she had experienced a 'shocking feeling' around the right side of her ribs and below her breast.The mri was aborted due to the 'shocking feeling' the patient experienced.On may 13, 2020, the cr reported that he was not informed of the mri being done and had not distributed the mri conditions to the mri facility (b)(6).The cr contacted the supervisor of the mri facility and was told that it was not the policy of the facility to contact the company if the information was available online.Mri facility supervisor also reported that the mri was aborted after three sequences of the patient's cervical spine.Cr also noted noncompliance with the ifu: ifu (document # 05-0234) page 21, in the notes section, states, "this information applies only to when a single stimulator is implanted." the patient, that underwent mri, has two stimulators implanted.On june 9, 2020, the cr reported that the patient is not activating the stimulators and therefore not receiving pain relief from the stimulators.Cr also reported that the mri facility was unable to verify the mri conditions due to it being aborted.Chief medical officer and quality management have been notified of the findings.The root cause of this complaint is attributed to noncompliance to the mri safety instructions in the ifu.Mri safety testing has not been conducted for multiple stimulators to determine mri safety or potential adverse events.The ifu (document 05-0234) page 21, in the notes section, states, "this information applies only to when a single stimulator is implanted." the mri conditions for two bilateral freedom-8a stimulator implants have not been validated and are not known.This complaint was attempted to be submitted on june 12th, 2020 but after some technical difficulties this attempt failed and it was resubmitted june 15th, 2020.

Event Description

Stimwave quality has investigated the details for a reported shock/jolt during mri, submitted to the stimwave complaint system on may 13, 2020, by clinical representative.

Manufacturer Narrative

On (b)(6) 2020, a survey was given to the patient to complete.In the survey the patient reported: feeling a shock (full body spasm), buzz (full body tingling), and/or jolt (particular body location spasmed).The patient reported that the sensation was strongest at the right rib cage and right breast.Patient did not have any additional hardware or implants.Patient had experienced this problem before with the mri.The patient reported feeling a burning sensation at the location of the stimulators.The patient reported experiencing a bad fall and/or some type of injury from strenuous activities since the date of the implant.On (b)(6) 2020, the cr reported that one of the stimulators, which was originally implanted at 8th thoracic vertebrae, migrated up to the 6th thoracic vertebrae.The other stimulator is still at 9th thoracic vertebrae.Implanting clinician is planning a revision procedure for the migrated stimulator.On (b)(6) 2020, cr reported that patient had still not scheduled revision.On (b)(6) 2020, mri survey results, x-rays, and investigations were presented to the chief medical officer.Chief medical officer believed the cause of this event may be due to mechanical movement of the migrated stimulator into a sensitive nerve ending during mri.The sandshark anchoring system was used for anchoring these stimulators.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 for a report of loss of therapy/migration submitted to the stimwave complaint system on june 11, 2020, by clinical representative (cr), in the united states.Cr became aware of this issue june 10, 2020.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10156185
• MDR Text Key: 200991418
• Report Number: 3010676138-2020-00052
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

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: 12/01/2020
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO181211, SWO190225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 07/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91