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U.S. Department of Health and Human Services

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

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STIMWAVE TECHNOLOGIES INC. STIMWAVE NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR Back to Search Results
Model Number FR8A-SPR-B0, FR8A-RCV-A0
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative

The implanting clinician examined the patient on (b)(6) 2020, identified potential infection, and prescribed antibiotics to the patient (type, dosage, duration unknown). The implanting clinician explanted the device on (b)(6) 2020, to prevent the infection from spreading. The implanting clinician stated to the stimwave clinical representative that the patient is prone to infections due to the patient being thin and not having adequate fatty tissue to act as a barrier between the coil and the skin. The explant procedure was conducted successfully without complication. The stimwave clinical representative confirmed that the implant procedure was performed in a sterile environment with sterile field handling protocols, sterile barriers of all products used were intact before the implant, and the procedure was completed following the product instructions for use. A review of sterilization and packaging records for the respective product lot swo200209 was performed: stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging. Based on this information, the infection was confirmed/replicated. There is no evidence that the product did not meet specifications. The stimulator is used for the treatment of pain. The cause of the infection is unknown/no problem found.

 
Event Description

On (b)(6) 2020, the patient reported feeling discomfort at the pocket/coil site and noticed the area had become inflamed and red.

 
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Brand NameSTIMWAVE NEUROSTIMULATOR
Type of DeviceSPINAL 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 Key11203106
MDR Text Key227815999
Report Number3010676138-2020-00190
Device Sequence Number1
Product Code GZB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberFR8A-SPR-B0, FR8A-RCV-A0
Device LOT NumberSWO200209, SWO200209
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/16/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/20/2021 Patient Sequence Number: 1
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