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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Twitching (2172)

Event Type  Injury  

Event Description

Initial info regarding unsolicited serious device case from united states was received from a pt on (b)(6) 2014.This case involves a (b)(6) male pt who experienced lost muscle control of legs, experienced switch, legs and arms started flailing on their own and whole body started to itch, few minutes after starting smart relief tens therapy (icy hot smart relief tens therapy starter kit back).The pt also experienced muscle spasms and felt like hit by a mack truck, unk duration after starting the therapy.Concomitant medications and relevant medical history: not provided.On an unk date, the pt started smart relief tens therapy (dose, route, form, frequency, lot/batch number and expiration date was not provided) for sore elbow.Pt used the device sore elbow for approx 3 minutes.Roughly an hour after usage, parts of pt's body started to itch intensely followed by itching in whole body.Minutes later, different parts of this body started to switch uncontrollably.Within 10 minutes, his legs and arms started flailing on their own and he lost muscle control of legs and arms.Pt went to an er and stayed there approx for 2 hours.They were able to control the violent flailing but pt still had minor muscle spasms (onset date was unk).Pt felt that he was hit by a mack truck (onset date was unk).Pt was positive that this device triggered this episode as nothing in his diet or routine had changed.Action taken: unk.Info on corrective treatment was not provided.Outcome was unk for all the events.Seriousness criteria: the event of lost muscle control of legs was medically significant.

Manufacturer Narrative

Pharmacovigilance comment: sanofi aventis company comment (b)(4) 2014: although the role of tens device cannot be denied for the event of loss of control of legs, however, sufficient (info is required regarding pt's concurrent condition, concomitant medications for a comprehensive assessment.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM, INC.; chattanooga TN
• Manufacturer Contact: michael murphy ; 55 corporate dr; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089813633
• MDR Report Key: 3842668
• MDR Text Key: 4681267
• Report Number: 1022556-2014-59210
• 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: Other
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: PREV MEDS = UNK; CON MEDS = UNK
• Patient Outcome(s): Other
• Patient Age: 42 YR