[89244447]
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.
Patient Sequence No: 1, Text Type: D, B5