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

Model Number FR8A-SPR-B0

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

During the implant procedure, the nurse notified the territory manager that the stimulator's shelf-life had exceeded.The territory manager confirmed this and exchanged the product prior to the implant.The implant procedure was completed without complications and there was no harm to the patient.No further complications were reported.The device was not implanted.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 as the 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-(b)(4) 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 clinical specialist must check all expiration dates and product models for accuracy per patient/clinician requirements before each procedure.Based on this information, the expired product was confirmed/replicated, the product did not meet specification and the stimulator is used for treatment of pain.The cause of the expired product was an issue with manufacturer material control issues.Device history record was reviewed and there were no non-conformances.

Event Description

Stimwave quality has investigated the details regarding a complaint resulting from an expired shelf-life device reported to stimwave on september 9, 2019, by territory manager.

• 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: 10425826
• MDR Text Key: 203674436
• Report Number: 3010676138-2020-00124
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004905
• UDI-Public: 010085961900490517190801
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2017
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO170828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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