MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INCORPORATED STIMWAVE IMPLANT; KIT STIIMULATOR RCVR 8 CONTACTS F, SPINAL CORD IMPLANT

Model Number S8UL-2

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 05/08/2017

Event Type  Injury  

Event Description

Stimwave trial implant movement from its origin site.On (b)(6) 2017, the pt underwent a surgery for stimwave trial implant placement.Per the surgeon, 2 octrode leads at t8 - t10 midline and t10 - mid to t12 were placed.On (b)(6) 2017, it was noted that the lead had moved cephalad to t3 and lateral along nerve root.On (b)(6) 2017, pt had an elective surgery to locate the tail of the stimwave lead followed by a laminectomy to completely remove it.The surgeon mentioned neither this was an expected complication nor the pt was at any higher risk for complications.So far, 3-4 devices have been implanted and 2 showed this issue.

• Brand Name: STIMWAVE IMPLANT
• Type of Device: KIT STIIMULATOR RCVR 8 CONTACTS F, SPINAL CORD IMPLANT
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INCORPORATED
• MDR Report Key: 7446387
• MDR Text Key: 106194555
• Report Number: MW5076573
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: S8UL-2
• Device Catalogue Number: S8UL-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2018
• 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): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 90