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

Device Problem Insufficient Information (3190)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Event Description

Initial information regarding this unsolicited case from united states was received from the patient on (b)(6) 2017.This case involves female patient of unknown age, who experienced atrial fibrillation, after starting treatment with smart relief tens therapy (icy hot smart relief tens therapy).Medical history included: atrial fibrillation.Past drugs and concomitant medications were not reported.On an unknown date, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number and expiry date: unknown) for back pain.The patient stated she had a fib (atrial fibrillation), and had it before using the smart relief.She stated she had a quick bout of a-fib (onset date: unknown) about 40 minutes after using the tens, but she said it was normal for her to get it sporadically.She wanted to be sure it was not caused by the smart relief.Action taken: unknown corrective treatment: not reported outcome: unknown seriousness criteria: important medical event pharmacovigilance comment: sanofi company comment dated (b)(6) 2017: this case concerns a female patient of unknown age who experienced atrial fibrillation after the use of the device; smart relief tens therapy used for back pain.The causal role of suspect device cannot be denied for the reported event; however this case lacks information regarding the condition of the skin at the contact area prior to applying the device leads (e.G., wet, dry, open wounds) and patient's medical history of atrial fibrillation for unknown duration is a confounder for the event.

Event Description

Initial information regarding this unsolicited case from united states was received from the patient on 30- may-2017.This case involves female patient of unknown age, who experienced atrial fibrillation, after starting treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy).Medical history included: atrial fibrillation.Past drugs and concomitant medications were not reported.On an unknown date, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number and expiry date: unknown) for back pain.The patient stated she had a fib (atrial fibrillation), and had it before using the smart relief.She stated she had a quick bout of a-fib (onset date: unknown) about 40 minutes after using the tens, but she said it was normal for her to get it sporadically.She wanted to be sure it was not caused by the smart relief.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Qa review was performed and investigation findings were reported as 'all retains are examined for correct packaging, seal, missing components, working control unit, legibility of lot numbers /expiration date, correct label and foreign matter.No anomalies were found that could contribute to this complaint'.Seriousness criteria: important medical event additional information was received from the quality department on 30-may-2017.Qa review findings were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 30-05-2017: the new follow up information received does not change the previous case assessment.Sanofi company comment dated 02-05-2017: this case concerns a female patient of unknown age who experienced atrial fibrillation after the use of the device; smart relief tens therapy used for back pain.The causal role of suspect device cannot be denied for the reported event; however this case lacks information regarding the condition of the skin at the contact area prior to applying the device leads (e.G., wet, dry, open wounds) and patient's medical history of atrial fibrillation for unknown duration is a confounder for the event.

• Brand Name: ICY HOT SMART RELIEF TENS BACK PAIN THERAPY
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM; 1715 west 38th street; chattanooga TN 37409
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 6629035
• MDR Text Key: 77280500
• Report Number: 1022556-2017-00003
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• 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: 05/30/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other