MAUDE Adverse Event Report: CHATTEM SMART RELIEF TENS THERAPY KNEE AND SHOULDER; TRANSCUTANEOUS NERVE STIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Seizures, Grand-Mal (2168)

Event Date 01/17/2016

Event Type  Injury  

Event Description

Initial information regarding this unsolicited device case from united states was received from the patient on (b)(6) 2016, processed together with csd of (b)(6) 2016.This case involves a (b)(6) female patient, who had a huge grand mal seizure, unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).Medical history 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: 14h133 and expiry date: unknown) for unknown indication.The patient stated she used to use the product years ago (past device) and when the battery quit she quit using it.Reportedly, she was thrilled to see it was available over the counter.Reportedly, she used it twice on (b)(6) 2016 and this morning (on (b)(6) 2016) at church she had a huge grand mal seizure (latency: unknown).Looking on line she saw where this can happen.Action taken: drug withdrawn nos.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event qa review was performed and investigation findings were reported as "the device history files were reviewed at the time of the complaint for any anomaly, deviation or investigation, documented or otherwise that might result in any type of complaint against the lot.No evidence of root cause was found in the device history files." pharmacovigilance comment: sanofi company comment dated 22-01-2016: this case concerns a (b)(6) female patient who experienced grand mal seizure after applying the device smart relief tens.Although the causal role of suspect device cannot be formally excluded.However lack of information about the usage of device, associated circumstances leading to the event along with the concomitants/past medication and details of medical history of the penitent precludes comprehensive assessment of the case.

Event Description

Initial information regarding this unsolicited device case from united states was received from the patient on (b)(6) 2016, processed together with csd of (b)(6) 2016.This case involves a (b)(6) female patient, who had a huge grand mal seizure, unspecified time after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).The patient had medical history of seizures in her sleep, concussions, she underwent knee surgery on (b)(6) 2015 and had not been taking the pain medication because the pain did not require them.Concomitant medication included oxcarbazepine.On (b)(6) 2016, the patient started therapy with smart relief tens therapy (lot/batch number and expiry date: unknown).The smart relief tens therapy device was purchased (b)(6) 2016 for a shoulder injury.The patient stated she used to use the product years ago (past device) and when the battery quit she quit using it.She was thrilled to see it was available over the counter.Reportedly, she used it twice on (b)(6) 2016 (once in the morning and once in the evening) and this morning (on (b)(6) 2016) at around 09:30 am at church she had a huge grand mal seizure (latency: unknown) and fell on the ground.Reportedly her eyes rolled back, she was biting her tongue and her arms were stiff.The patient was not stressed at the time of event.She did not seek any medical treatment after the event, went home and she went to bed.The patient then had 02 more grand mal seizures within a 50 hour time period.She informed that she had not used the product on sunday ((b)(6) 2016) and did not have it on when the seizure occurred.The patient did not have a fever, illness, was not sleep deprived or dehydrated.There was no trigger or warning before the seizure, and that this seizure was the worst the patient has ever had.The patient thought that something was wrong with this product because she only felt stimulation after holding the device down and turning it way up.She did not know what intensity level it was on because it didn't seem to be working properly.The device was being used on her right shoulder.She also had a history of concussions and thought that to be reason for occurrence of her seizures.However they had only ever occurred during her sleep, and never like this before.Later on she mentioned that the doctor thought they were caused by stress.The last seizure was more than a year ago, she has little "absent seizures" but this was the most violent seizure she has ever had.The patient was recommended to seek medical attention.Action taken: drug withdrawn nos.Outcome: unknown.Seriousness criteria: important medical event qa review was performed and investigation findings were reported as "the device history files were reviewed at the time of the complaint for any anomaly, deviation or investigation, documented or otherwise that might result in any type of complaint against the lot.No evidence of root cause was found in the device history files." additional information was received on (b)(6) 2016 from the patient: medical history and concomitant medication added, therapy start date for smart relief tens therapy was added as (b)(6) 2016' and indication was added as 'shoulder injury', information on corrective treatment added, details regarding event (symptoms added, it was informed that the product was not in use at the time of event, information on trigger factors and last episode of seizure prior to event) added, clinical course updated and narrative was updated accordingly.Pharmacovigilance comment: sanofi company comment dated 22-01-2016: this case concerns a (b)(6) female patient who experienced grand mal seizure after applying the device smart relief tens.Although the causal role of suspect device cannot be formally excluded.However the patient's medical history of convulsions is a confounding factor for this event.

Event Description

Initial information regarding this unsolicited device case from united states was received from the patient on 17-jan-2016 and 18-jan-2016, processed together with csd of 17-jan-2016.This case involves a (b)(6) female patient, who had a huge grand mal seizure, one day after she started using smart relief tens therapy (smart relief tens therapy knee and shoulder).The patient had medical history of seizures in her sleep, concussions, she underwent knee surgery on (b)(6) 2015 and had not been taking the pain medication because the pain did not require them.Concomitant medication included oxcarbazepine.On (b)(6) 2016, the patient started therapy with smart relief tens therapy (lot/batch number and expiry date: unknown).The smart relief tens therapy device was purchased (b)(6) 2016 for a shoulder injury.The patient stated she used to use the product years ago (past device) and when the battery quit she quit using it.She was thrilled to see it was available over the counter.Reportedly, she used it twice on (b)(6) 2016 (once in the morning and once in the evening) and this morning (on (b)(6) 2016) at around 09:30 am at church she had a huge grand mal seizure (latency: unknown) and fell on the ground.Reportedly her eyes rolled back, she was biting her tongue and her arms were stiff.The patient was not stressed at the time of event.She did not seek any medical treatment after the event, went home and she went to bed.The patient then had 02 more grand mal seizures within a 50 hour time period.She informed that she had not used the product on ((b)(6) 2016) and did not have it on when the seizure occurred.The patient did not have a fever, illness, was not sleep deprived or dehydrated.There was no trigger or warning before the seizure, and that this seizure was the worst the patient has ever had.The patient thought that something was wrong with this product because she only felt stimulation after holding the device down and turning it way up.She did not know what intensity level it was on because it didn't seem to be working properly.The device was being used on her right shoulder.She also had a history of concussions and thought that to be reason for occurrence of her seizures.However they had only ever occurred during her sleep, and never like this before.Later on she mentioned that the doctor thought they were caused by stress.The last seizure was more than a year ago, she has little "absent seizures" but this was the most violent seizure she has ever had.The patient was recommended to seek medical attention.Action taken: drug withdrawn nos.Outcome: unknown.Seriousness criteria: important medical event.Qa review was performed and investigation findings were reported as "the device history files were reviewed at the time of the complaint for any anomaly, deviation or investigation, documented or otherwise that might result in any type of complaint against the lot.No evidence of root cause was found in the device history files." the consumer was not wearing the tens device at the time of the grand mal seizure; they had used it twice the night before.Additionally, when the consumer was using the device, they stated that additional pressure was required to feel stimulation.Therefore, erratic or overstimulation output was likely not occurring.The consumer states that they have had seizures in the past.The occurrence of this adverse event is not linked to any device malfunction.The consumer returned the device to the retailer, so return is not expected.Therefore, no investigation can be performed at this time.Additional information was received on 25-jan-2016 from the patient: medical history and concomitant medication added, therapy start date for smart relief tens therapy was added as (b)(6) 2016' and indication was added as 'shoulder injury', information on corrective treatment added, details regarding event (symptoms added, it was informed that the product was not in use at the time of event, information on trigger factors and last episode of seizure prior to event) added, clinical course updated and narrative was updated accordingly.Additional information was received on 25-jan-2016, qa review finding was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 25-01-2016: follow up information does not change the previous assessment of this case.Sanofi company comment dated 22-01-2016: this case concerns a (b)(6) female patient who experienced grand mal seizure after applying the device smart relief tens.Although the causal role of suspect device cannot be formally excluded.However the patient's medical history of convulsions and concussion is a confounding factor for this event.

• Brand Name: SMART RELIEF TENS THERAPY KNEE AND SHOULDER
• 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: 5395593
• MDR Text Key: 36948766
• Report Number: 1022556-2016-00002
• 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,Followup
• Report Date: 01/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• 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: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR