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

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

Device Problems Break (1069); Migration (4003)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

The implanting clinician attempted to revise the proximal end of the stimulator and also removed a granuloma that was near the area where the stimulator fractured.In the midst of this operation the receiver came out of the stimulator, indicating to the implanting clinician that the stimulators had fractured and migrated, causing loss of therapy.On (b)(6) 2020, the patient had a revision in which both stimulators were removed and two new stimulators were implanted.The revision was completed without complication and the patient has reported receiving therapy.On (b)(6) 2020, the cr stated that the implanting clinician believes that the stimulator fracture resulting in migration is due to a granuloma forming around the stimulator and causing tension.The patient was reported to be doing well and no further issues were noted.Through a review of sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, no trend of infection is evident for lot #'s swo190414 and swo190424, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Sterility of the stimwave device did not contribute to granuloma formation.The root cause of this complaint is due to a granuloma forming around the stimulators, causing them to fracture and migrate leading to a loss of therapy.

Event Description

On (b)(6) 2020, the patient met with the implanting clinician reporting loss of therapy.The clinician observed via x-ray that both stimulators had fractured.

• 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,
• 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: 10084230
• MDR Text Key: 199090747
• Report Number: 3010676138-2020-00047
• Device Sequence Number: 1
• Product Code: GZF
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2021
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO190414, SWO190424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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