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U.S. Department of Health and Human Services

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

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CHATTEM ICY HOT SMART RELIEF TENS BACK PAIN THERAPY TRANSCUTANEOUS NERVE STIMULATOR Back to Search Results
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.
 
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Brand NameICY HOT SMART RELIEF TENS BACK PAIN THERAPY
Type of DeviceTRANSCUTANEOUS 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 Key6629035
MDR Text Key77280500
Report Number1022556-2017-00003
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131159
Number of Events Reported1
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 Received06/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/09/2017 Patient Sequence Number: 1
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