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

Model Number STQ4-SPR-B0

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Skin Infection (4544)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, inadequate fixation, the patient going through and mri, not irrigating the incision site with antibiotic solution, not prescribing antibiotics pre-operatively, implanting a broken stimulator, implanting an expired stimulator, not prepping the skin with antiseptic solution, not irrigating the incision site, using inappropriate tools and multiple tunneling attempts have been ruled out as potential causes of the reported issue.However, it is believed the suture made by the physician for the coil failed, causing the migration, erosion, and then minor infection.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 stimulator is used to treat pain.The cause of the reported issue is due to incorrect surgical technique as the suture made by the physician at the coil failed (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.

Event Description

The patient reported migration, erosion and infection.Antibiotics were prescribed and partial explant procedure was performed on (b)(6), 2022.On (b)(6) 2022, the remaining parts of the stimulator were explanted, antibiotic wash was used and stitches were placed to close the wound.No further issues have been reported.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL 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: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 15154477
• MDR Text Key: 297140582
• Report Number: 3010676138-2022-00096
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240201
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2024
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO220228
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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