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

Model Number FR8A-SPR-B0

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

The clinical representative confirmed that the implant procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.On (b)(6) 2020, cr reported covering case and she stated implanting clinician was implanting sand shark over the lead when he severed lead with bevel of sand shark.He removed the severed lead with no issues and re implanted new lead new sand shark.On (b)(6) 2020, cr contacted complaint specialist on the phone to report that the patient had not been in contact.On (b)(6) 2020, complaint specialist, reviewed sterilization and packaging records for the respective product lots, stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging for lots swo191113.The stimulator was reported to meet product specifications.Manufacturer cannot currently receive the stimulator for analysis.The device was used for treatment of pain.The device cannot be traced as the source of the issue.

Event Description

Stimwave quality has investigated the details regarding a complaint of fractured stimulator reported to stimwave's complaint system on (b)(6) 2020, by clinical representative (cr), in the united states.Stimwave became aware of the issue on (b)(6) 2020.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach 33064
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach 33064
• MDR Report Key: 10597408
• MDR Text Key: 208933319
• Report Number: 3010676138-2020-00134
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817211101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2021
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO191113
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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