MAUDE Adverse Event Report: TENS - SHOULDER THERAPY DEVICE; STIMULATOR, NERVE, TRANSCUTANEOUS

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

Patient Problems Heart Failure (2206); Loss of consciousness (2418)

Event Type  Injury  

Event Description

Patient called to report an adverse event that took place while using a tens shoulder therapy device.Patient stated that as soon as her therapy started with the device, she blacked out and had heart failure.Patient stated she spent time in the icu and rehab and almost died.

• Brand Name: TENS - SHOULDER THERAPY DEVICE
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS
• MDR Report Key: 7380897
• MDR Text Key: 103983619
• Report Number: MW5076210
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 94 YR