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

Lot Number UNKNOWN

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on (b)(6) 2017.This case concerns a (b)(6) male patient who experienced mini stroke after using smart relief tens therapy (smart relief tens therapy back).The patient had 2 metal hip replacements.No past drugs and concomitant medicates were reported.On an unknown date in 2017 (1-2 months ago), the patient started using smart relief tens therapy (lot/ batch number and expiry date: unknown).The electrode pad lot/batch number: b160912 and expiry date: 31-may- 2019, control unit serial number: (b)(4).It was reported that he had the icy hot smart relief tens therapy back/back and hip for a month or two and no longer had the box.He recently had a mini stroke (onset date: 2017 and latency unknown) and had a loop recorder (corrective treatment) put in under his skin a month ago but had not used the device with it yet.He had also read something on the smart relief tens therapy and it said not to use if one had a pace maker or any device in him/her (it was not recommend using the device).Later, he went to use it and put it on but it was not turning on.Reportedly, he liked the product and was getting relief but could not use it under the circumstances.Action taken: unknown outcome: unknown seriousness criteria: important medical event this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive (b)(4).And module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Pharmacovigilance comment: sanofi company comment for dated (b)(6) 2017: this case concerns a (b)(6) male patient who reported mini stroke while on treatment with smart relief tens therapy.Although the causal role of the drug cannot be denied for the reported event, more information regarding latency, concurrent illness, concomitant medications, past drugs, personal and history regarding sedentary lifestyle can aid in comprehensive case assessment.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 18- sep-2017.This case concerns a (b)(6) year old male patient who experienced mini stroke after using smart relief tens therapy (smart relief tens therapy back).The patient had had 2 metal hip replacements.No past drugs and concomitant medicates were reported.On an unknown date in 2017 (1-2 months ago), the patient started using smart relief tens therapy (lot/ batch number and expiry date: unknown).The electrode pad lot/batch number: b160912 and expiry date: 31-may- 2019, control unit serial number: (b)(4).It was reported that he had the icy hot smart relief tens therapy back/back and hip for a month or two and no longer had the box.He recently had a mini stroke (onset date: 2017 and latency unknown) and had a loop recorder (corrective treatment) put in under his skin a month ago but had not used the device with it yet.He had also read something on the smart relief tens therapy and it said not to use if one had a pace maker or any device in him/her (it was not recommend using the device).Later, he went to use it and put it on but it was not turning on.Reportedly, he liked the product and was getting relief but could not use it under the circumstances.Action taken: unknown.Outcome: unknown.Seriousness criteria: important medical event.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Qa review finding: this case was reported and classification/issue codes were updated to reflect adverse event consumer experienced; the mini-stroke did not occur during device use.Received one tens unit serial number (b)(4), one panasonic battery, and one electrode lot number b-16-09-12 for investigation.Upon visual inspection, the tens unit was in good condition.The measured voltage of the received battery confirmed that it was dead.However, the unit was fully functional with a new battery; complete and consistent stimulation was output.No erratic output was noted.The pad was in bad condition but stored on a clear, protective sheet; it was dirty and the gel was peeling from the pad.The left impedance readings of the pad were 540ohm and 600ohm, and the right impedance readings were 520ohm and 630ohm.Impendence readings were uniform across several pad locations; no hot spots were noted.The bad condition of the pad indicates functionality.While the worn device components will inhibit device from effectively relieving pain, the adverse event the consumer experienced could not be attributed to any device malfunction.Final conclusion: dead battery / worn pad additional information was received on 21-sep-2017 from quality department, qa review findings added.Text amended.Additional information was received on 05-oct-2017 from quality department, qa review findings and sample status updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated 05-10-2017: the new follow-up information received does not change the prior assessment of the case.Sanofi company comment for dated 18-09-2017: this case concerns a (b)(6) year- old male patient who reported mini stroke while on treatment with smart relief tens therapy.Although the causal role of the drug cannot be denied for the reported event, more information regarding latency, concurrent illness, concomitant medications, past drugs, personal and history regarding sedentary lifestyle can aid in comprehensive case assessment.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 18- sep-2017.This case concerns a (b)(6) year old male patient who experienced mini stroke after using smart relief tens therapy (smart relief tens therapy back).The patient had 2 metal hip replacements.No past drugs and concomitant medicates were reported.On an unknown date in 2017 (1-2 months ago), the patient started using smart relief tens therapy (lot/ batch number and expiry date: unknown).The electrode pad lot/batch number: b160912 and expiry date: 31-may- 2019, control unit serial number: (b)(4).It was reported that he had the icy hot smart relief tens therapy back/back and hip for a month or two and no longer had the box.He recently had a mini stroke (onset date: 2017 and latency unknown) and had a loop recorder (corrective treatment) put in under his skin a month ago but had not used the device with it yet.He had also read something on the smart relief tens therapy and it said not to use if one had a pace maker or any device in him/her (it was not recommend using the device).Later, he went to use it and put it on but it was not turning on.Reportedly, he liked the product and was getting relief but could not use it under the circumstances.Patient had to stop using product because of loop recorder battery put in his chest after having a mini stroke.Action taken: drug withdrawn nos on unknown date.Outcome: recovered on unknown date.Seriousness criteria: important medical event.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively.To ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Qa review finding: this case was reported and classification/issue codes were updated to reflect adverse event consumer experienced; the mini-stroke did not occur during device use.Received one tens unit serial number (b)(4), one panasonic battery, and one electrode lot number b-16-09-12 for investigation.Upon visual inspection, the tens unit was in good condition.The measured voltage of the received battery confirmed that it was dead.However, the unit was fully functional with a new battery; complete and consistent stimulation was output.No erratic output was noted.The pad was in bad condition but stored on a clear, protective sheet; it was dirty and the gel was peeling from the pad.The left impedance readings of the pad were 540ohm and 600ohm, and the right impedance readings were 520ohm and 630ohm.Impendence readings were uniform across several pad locations; no hot spots were noted.The bad condition of the pad indicates functionality.While the worn device components will inhibit device from effectively relieving pain, the adverse event the consumer experienced could not be attributed to any device malfunction.Final conclusion: dead battery / worn pad.Additional information was received on 21-sep-2017 from quality department, qa review findings added.Text amended.Additional information was received on 05-oct-2017 from quality department, qa review findings and sample status updated.Text amended accordingly.Additional information was received on 13-oct-2017 from the patient: patient demographics (height and weight) added.Action taken and event outcome updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow-up dated 13-10-2017: the new follow-up information received does not change the prior assessment of the case.Sanofi company comment for dated 18-09-2017: this case concerns a (b)(6)-year- old male patient who reported mini stroke while on treatment with smart relief tens therapy.Although the causal role of the drug cannot be denied for the reported event, more information regarding latency, concurrent illness, concomitant medications, past drugs, personal and history regarding sedentary lifestyle can aid in comprehensive case assessment.

Event Description

Initial information regarding this unsolicited case from united states was received from a patient on 18- sep-2017.This case concerns a (b)(6) year old male patient who experienced mini stroke after using smart relief tens therapy (smart relief tens therapy back).The patient had 2 metal hip replacements.No past drugs and concomitant medicates were reported.On an unknown date in 2017 (1-2 months ago), the patient started using smart relief tens therapy (lot/ batch number and expiry date: unknown).The electrode pad lot/batch number: b160912 and expiry date: 31-may- 2019, control unit serial number: (b)(4).It was reported that he had the icy hot smart relief tens therapy back/back and hip for a month or two and no longer had the box.He recently had a mini stroke (onset date: 2017 and latency unknown) and had a loop recorder (corrective treatment) put in under his skin a month ago but had not used the device with it yet.He had also read something on the smart relief tens therapy and it said not to use if one had a pace maker or any device in him/her (it was not recommend using the device).Later, he went to use it and put it on but it was not turning on.Reportedly, he liked the product and was getting relief but could not use it under the circumstances.Action taken: unknown.Outcome: unknown.Seriousness criteria: important medical event.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Qa review finding: the device history files are reviewed 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.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.The pcb test data confirmed that all inspection steps were passed for control unit serial number (b)(4) and rework was not required.Additionally, the coa for electrode lot number b-16-09-12 confirmed that all inspection items were passed.Device return is expected; if/when it is returned, further investigation may be performed.Additional information was received on 21-sep-2017 from quality department, qa review findings added.Text amended.Pharmacovigilance comment: sanofi company comment for follow-up dated 21-09-2017: the new follow-up information received does not change the prior assessment of the case.Sanofi company comment for dated 18-09-2017: this case concerns a (b)(6) -year- old male patient who reported mini stroke while on treatment with smart relief tens therapy.Although the causal role of the drug cannot be denied for the reported event, more information regarding latency, concurrent illness, concomitant medications, past drugs, personal and history regarding sedentary lifestyle can aid in comprehensive case assessment.

• Brand Name: SMART RELIEF TENS 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: 6939473
• MDR Text Key: 89244447
• Report Number: 1022556-2017-00009
• 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,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 09/21/2017; 10/05/2017; 10/13/2017
• Supplement Dates FDA Received: 10/13/2017; 10/16/2017; 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 107