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

Model Number FR8A-SPR-B0

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erythema (1840); Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Implanting clinician performed a revision on the same date as the follow-up.However, when the incision was made, the lead had migrated.The implanting clinician decided to perform an explant on (b)(6) 2021.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, implanting an expired device, not using antibiotics, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.The implanting clinician stated that the cause of the infection/ tenderness is 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 stimulator is used to treat pain.The cause of the infection/tenderness is patient non-compliance to the ifu (patient user error).

Event Description

Post- operatively, patient returned to physician reporting an infection and soreness and discomfort at the incision site.The implanting physician attempted to drain the incision area, and notes the leads had migrated.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD 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: 12108285
• MDR Text Key: 259704583
• Report Number: 3010676138-2021-00136
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817230101
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO210125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• 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): Other; Required Intervention