MAUDE Adverse Event Report: UNKNOWN UNKNOWN TENS UNIT; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  Injury  

Event Description

The patient reported they noticed their stimulation felt stronger after they used their tens therapy since it was implanted on (b)(6) 2015.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN TENS UNIT
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17529481
• MDR Text Key: 321135808
• Report Number: MW5136407
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1