MAUDE Adverse Event Report: STIMWAY IMPLANT SPINAL CORD STIMULATOR FOR PAIN; KIT STIMULATOR RCVR 8 CONTACTS F

Model Number S8UL-2

Device Problem Communication or Transmission Problem (2896)

Patient Problem Pain (1994)

Event Date 06/12/2017

Event Type  Injury  

Event Description

Stimwave implants movement from its origin site.On (b)(6) 2017, the patient underwent a spinal surgery for placement of stimwave system entered at t 12/l1 and t11/t12 levels.This procedure was performed as a treatment for the patient's chronic back pain.Per the surgeon, on (b)(6) during a post-operative check to assess function, the implant was noted on to have moved cephalad - one of the leads.As the lead had moved such that it would possibly require a laminectomy to remove it.On (b)(6) 2017, it was noted to have moved further cephalad.The surgeon stated that she contacted the manufacturer after this occurrence.She was told that they knew about this issue but did not communicate to her in advance.Per the surgeon, so far, 3-4 devices have been implanted and 2 showed this issue.

• Brand Name: STIMWAY IMPLANT SPINAL CORD STIMULATOR FOR PAIN
• Type of Device: KIT STIMULATOR RCVR 8 CONTACTS F
• MDR Report Key: 7472667
• MDR Text Key: 107068757
• Report Number: MW5076893
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: S8UL-2
• Device Catalogue Number: S8UL-2
• Device Lot Number: SW0170102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 92