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

Model Number FR8A-RCV-A0, FR8A-RCV-A0

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, following the implant procedure, the implanting clinician was made aware by the assisting nurse that the devices' expiration dates preceded the date of implant.The implanting clinician determined that the issue did not require explant of the devices.The implanting clinician decided to monitor the patient for possible infections or complications related to the devices.The distributor confirmed on august 1, 2019, that the patient was doing well.The patient's wounds were healing, and no infections were reported.The devices remain implanted and the patient is receiving therapy.The expiration date in the product's labeling indicates the validated shelf life for the product, which has been validated through shelf life studies (accelerated aging (06-0580) and real time aging (06-01723)).Neither the product's sterility nor performance is affected given the two-week timeframe between product expiration (2019-07-01) and use ((b)(6) 2019), as he sterile barriers have not been compromised.Currently, an extended shelf life study initiated on march 19, 2018, is underway to evaluate extending product expiration date to at least five (5) years; this data will verify product sterility and performance for the extended time period (refer to capa-0030 for full correction details).A review of current procedures confirmed that field personnel are required to verify the expiration date of the stimulator prior to implant.Additionally, a review of shipping and receiving procedures indicated that there is no implemented process to prevent expired products from being shipped out.The operating room procedures (50-0129, page 3) state: the root cause of the event is attributed to a combination of manufacturer and clinician - user error.

Event Description

Stimwave quality is investigating the details of a complaint resulting from two (2) stimulators implanted past shelf life expiration date that was reported to stimwave on (b)(6) 2019, by stimwave agent.

• Brand Name: FREEDOM NEUROSTIMULATOR
• 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: 10425859
• MDR Text Key: 208982123
• Report Number: 3010676138-2020-00121
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2019
• Device Model Number: FR8A-RCV-A0, FR8A-RCV-A0
• Device Lot Number: SWO10725, SWO170630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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