MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 2) POCKET PAIN PRO; TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR T.E.N.S

Model Number PM3029

Device Problem Insufficient Information (3190)

Patient Problem Tachycardia (2095)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unit has been received and device evaluation is in progress.Consumer admitted using the device off label.The u.S importer is requesting the manufacturer of the device to further investigate this incident.The product labeling states the following under important safety precautions and warnings: " never apply the pads to these body areas: the neck or any area of the throat because this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure." a root cause has not been determined.It has not been confirmed whether the device caused or contributed to the reported incident.However, due to the customer using the device off label and calling an ambulance and getting treatment for increased heart rate, this medwatch is being filed.

Event Description

Consumer reported she used her unit for an hour on her neck area on (b)(6) 2018.She woke up with her heart racing and called an ambulance.When she was in the ambulance, they hooked her up to an ekg and iv.They gave her medication but she does not know what it was.There was no change with single dose of the medication, so they doubled the dose.Consumer stated by the time she arrived at the hospital, everything was normal.They did ekg, x-ray and blood work.She was advised to follow up with her physician.Consumer stated when she used her unit; she sat on her recliner or rocking chair.She was using the unit for 15 minutes once a day.Consumer stated she has given the unit to her doctor but she will try to get it back and send it for further investigation.Customer service representative informed consumer that postage paid label is sent to her to retrieve the unit.During follow-up call with quality analyst, consumer stated she put the pads on her neck and ended up calling an ambulance and going to er.She has had the unit since the fall, and was the only user, and used the unit normally 5 times a week with 15 minute sessions.She used the unit on her trapezius muscles for an hour straight on (b)(6).She has degenerative disks so she had to use it on her trapezius area.Consumer stated this is all her fault because she used the pads for an hour straight and read the instruction manual after all of this and noticed it states to not put on your neck area.Consumer stated the ambulance gave her pills because her heart rate was 212.When she got to hospital, they did ekg, blood work and everything came back normal.She called her cardiologist and she had to wear a heart monitor at night but the results came back normal.Consumer would like a refund.A postage paid label has been sent for retrieval of the home unit for inspection.During follow-up call on (b)(6) 2018 with quality department consumer stated she has already mailed the unit back for inspection so cannot provide serial lot number.Consumer insisted that it was her own fault, she had misused the unit.She has been on atenolol for hypertension and lipitor for high cholesterol.Consumer was using the unit since fall but was using on her shoulder and this time she used it all the way up on her neck.Consumer repeatedly stated it was her fault.Consumer indicated when she used it "properly" she really liked it and it helped her a lot; she was able to get good night sleep.Consumer did not remember name of the medication she was given in the ambulance but it was to control her heart rate.She does not have pacemaker or any implanted metallic or electronic devices.Consumer again stated she is a retired teacher and she should know that she should be reading the instructions prior to using the unit.

Manufacturer Narrative

Exemption number: e2013031.Omron healthcare.Inc.(importer) is submitting the report on behalf of omron (dalian) co., ltd.(plant 2) (manufacturer).Registration number: (b)(4).The unit was returned on 02/27/2018.The returned unit was evaluated by importer (u.S agent).Then the customer returned device was sent to the device manufacturer for further investigation.Here is the summary of the manufacturer device investigation: the manufacturer applied 3.0 v with stabilized power supply, but the device would not turn on.When the unit was disassembled and the internal parts checked; the fuse was found to be blown.Based on further testing, it was determined that the fuse had blown due to increase of consumption current inside the cpu.The severity of harm of this malfunction is judged to be "none" because the main unit does not operate due to disconnection of the fuse.Therefore, correction is unnecessary.The manufacturer was unable to perform further testing.The state of product was possibly changed during transportation from importer to manufacturer.The manufacturer reviewed the qa test data and complaint history for similar issues.No issue or increasing trend was noted.The risk analysis document was reviewed and it was determined no update to risk management documents is required.The complaint could not be confirmed.No further investigation required.

• Brand Name: POCKET PAIN PRO
• Type of Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR T.E.N.S
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 2); no. 28 dongbei er street, eco-; nomic & technical development; dalian liaoning, 11660 0; CH 116600
• MDR Report Key: 7300559
• MDR Text Key: 101117891
• Report Number: 3003263296-2018-00002
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• PMA/PMN Number: K141978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PM3029
• Device Catalogue Number: PM3029
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/15/2018
• Device Age: 8 MO
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 90