MAUDE Adverse Event Report: NEUROTHERM NEUROTHERM; SIMPLICITY III RF ELECTRODE

Model Number REF RFDE-SI

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

Sacroiliac radio frequency ablation probe was placed in the patient, once placement was confirmed the 3 cords were inserted into the neurotherm so the physician could start the burn.Once the plugs were in, it was noted only 2 of the 3 plugs were active for use.Attempts were made to call the representative for our clinic without success.The probe was then removed, and the physician reinserted a new probe, and successfully completed the procedure.

• Brand Name: NEUROTHERM
• Type of Device: SIMPLICITY III RF ELECTRODE
• Manufacturer (Section D): NEUROTHERM; wilmington MA 01887
• MDR Report Key: 3950828
• MDR Text Key: 4603899
• Report Number: 3950828
• Device Sequence Number: 1
• Product Code: GXD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: REF RFDE-SI
• Device Lot Number: 131130-2D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/02/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 121