MAUDE Adverse Event Report: CHATTEM ICY HOT SMART RELIEF TENS THERAPY; TRANSCUTANEOUS NERVE STIMULATOR

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Sweating (2444); Palpitations (2467)

Event Date 01/03/2016

Event Type  Injury  

Event Description

Initial information regarding this unsolicited device case from united states was received from the patient on (b)(6) 2016.This case involves a male patient of unknown age, who felt a little flutter in his heart, blood pressure which was 98/53, broke out in a sweat and little woozy, same day after he started using smart relief tens therapy (icy hot smart relief tens therapy).The patient has a medical history of high blood pressure, high cholesterol and had a recent back surgery.Past drugs and concomitant medications were not reported.On (b)(6) 2016 (couple of hours ago), the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number and expiry date: unknown) for unknown indication.He stated it was working well but he then felt a little flutter in his heart, broke out in a sweat and took his blood pressure which was 98/53 on same day (onset date: (b)(6) 2016).Reportedly, on same day he still felt a little woozy.He stated he was supposed to get a spinal stimulation but wanted to try this product first.Patient was told to not use the product anymore until he speak with a physician and discussed the symptoms were concerning and these should be medically evaluated and do not drive yourself.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event of felt a little flutter in his heart and bp which was 98/53.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2016: this case concerns a male patient who experienced palpitation and blood pressure decreased while using the device smart relief tens.The causal role of suspect device cannot be formally excluded, however the medical history of patient may be a plausible factor for the occurrence of the events.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM; 1715 west 38th street; chattanooga TN 37409
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5359627
• MDR Text Key: 35623232
• Report Number: 1022556-2016-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• PMA/PMN Number: K131159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other