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

Model Number	FR8A-RCV-B0
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10424436
• Report Number: 3010676138-2020-00104
• Device Sequence Number: 11680552
• Product Code: GZB
• UDI-Device Identifier: 00859619004882
• UDI-Public: 010085961900488217190101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention