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

Model Number FRE4-A000, FRE4-A000

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Migration is a known cause of loss of therapy.The patient decided to have the stimulators explanted rather than have a revision to correct the migration.When explanting the stimulator, the physician noticed lead electrode breakage and migration, possibly intrathoracically.The lead was removed during the procedure, with no further issues reported.The remainder of the stimulator was fully retrieved.Based on this information, the fractured stimulator 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 fractured stimulator is unknown/no problem found.

Event Description

The patient was implanted with two stimulators (fr4-a000 and fr4-a000).The patient received good stimulation after the implant procedure.However, on (b)(6) 2019, the patient was implanted with a new lead.The reason why the patient needed an additional lead implanted is unknown.An x-ray confirmed migration.

• 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: 10737984
• MDR Text Key: 213221975
• Report Number: 3010676138-2020-00151
• Device Sequence Number: 1
• Product Code: GZB
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2019
• Device Model Number: FRE4-A000, FRE4-A000
• Device Lot Number: SWO171109, SWO171109
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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