MAUDE Adverse Event Report: BIONESS INC. BIONESS STIMROUTER ELECTRODE; STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Model Number ST2-1000

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/13/2021

Event Type  Injury  

Event Description

We implanted a bioness stimrouter device in the right suprascapular nerve in (b)(6) 2020, which migrated out of the suprascapular notch.On removing the electrode today, we carefully extracted the proximal aspect and the electrode broke in half.Significantly more time and deep tissue dissection into the supraspinatus region was required to extract the foreign body.Patient was having severe pain for the last 9 months, and will have prolonged recovery due to lead extraction difficulty.Fda safety report id # (b)(4).

• Brand Name: BIONESS STIMROUTER ELECTRODE
• Type of Device: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): BIONESS INC.
• MDR Report Key: 13019548
• MDR Text Key: 282395713
• Report Number: MW5106097
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST2-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic