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

Model Number FR8A-RCV-A0

Device Problem Fracture (1260)

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

Event Date 09/26/2022

Event Type  Injury  

Event Description

The patient reported loss of therapy.After several unsuccessful attempts of reprogramming, an explant procedure was performed on (b)(6) 2022.Following the explant procedure, it was identified the antenna inside the lead was broken.The clinical representative confirmed at the time of the implant, the antenna in the lead was intact and paresthesia was achieved initially following the implant procedure.The entire lead was explanted.

Manufacturer Narrative

The loss of therapy/no therapy issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, migration, implanting the device at an off-label location, not achieving paresthesia on the table, no attempts to reprogram the device, and inadequate fixation have been ruled out as potential causes.The clinical representative confirmed the patient did not suffer a fall nor engage in twisting, bending or lifting heavy objects.The stimulator is used to treat pain.The cause of the loss of therapy is likely due to the broken antenna in the lead.However, the cause of the broken antenna is unknown.Therefore, conclusion has been selected as no problem/fault found.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, capa is not required. loss of therapy/no therapy issue rates will continue to be tracked and trended.

• 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 FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 15642455
• MDR Text Key: 302160634
• Report Number: 3010676138-2022-00124
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004073
• UDI-Public: (01)00859619004073(17)221201
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K182720
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO201216A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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