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

Model Number STQ4-RCV-A0

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

The implanting clinician prescribed antibiotics to the patient (name, dosage, frequency, unknown).The surgical issue questionnaire was reviewed for potential caused of the reported issue.Based on this review, implanting a non-sterile device, not irrigating the incision site, not using antibiotics, not prepping the skin, using inappropriate tools and multiple tunneling attempts have been ruled out as potential causes.The implanting clinician stated that the cause of the infection was unknown.However, the questionnaire shows that the patient was not in compliance with the ifu by touching/picking at the wound.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The cause of the infection is patient error and non-compliance to the ifu.

Event Description

The stimulator was explanted successfully on (b)(6) 2021, due to infection, and no further issues have been reported.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL NERVE 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: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 11852789
• MDR Text Key: 251662330
• Report Number: 3010676138-2021-00093
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020464
• UDI-Public: 010081822502046417221001
• 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: Other
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2011
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO201029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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