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

Model Number FR8A-RCV-B0

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Patient was enrolled in an approved ide clinical study ((b)(6)) and was implanted with two stimulators (fr8a-rcv-a0 and fr8a-rcv-b0).The patient received good stimulation in operating and recovery rooms, but a few days later, was not receiving adequate stimulation for pain relief.X-ray confirmed cephalad migration of the b0 stimulator.The patient decided to have the stimulators explanted rather than have a revision to correct the migration.The a0 stimulator was explanted without issue.When explanting the b0 stimulator, the clinician (dr.(b)(6)) noticed that the stimulator was fracturing at or around the marker band.A separate incision was made below the marker band and the remainder of the stimulator was fully retrieved.The patient did not experience injury, illness, or infection.

Event Description

Stimwave quality has investigated the details surrounding a complaint resulting from an explant procedure with clinician and therapy specialist on (b)(6) 2017.The stimulator explant was successfully completed, however, the device was literally "pulled" apart during the explant.However, this event did not result in any injury to the patient and therefore the clinician and specialist filed the official complaint in the same week, but not on the day of the incident.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10424436
• MDR Text Key: 203838150
• Report Number: 3010676138-2020-00104
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00859619004882
• UDI-Public: 010085961900488217190101
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Model Number: FR8A-RCV-B0
• Device Lot Number: SWO170113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2017
• 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