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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

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TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF Back to Search Results
Device Problems Defective Device (2588); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  Injury  
Event Description
I was supplied with a tens unit by (b)(6) (through my physical therapist's office) in approx (b)(6) of 2018.My insurance company paid for the unit.Shortly after i received the unit, i began receiving monthly supplies of batteries, extra cords, and electrode patches.My insurance was billed monthly for these supplies ($(b)(6)).The batteries were defective, essentially all of them were dead.I would put them into the tens unit, and if it was a good day, the battery would work for 10 seconds.Other batteries didn't work at all.Not only that, the quality of the electrode patches was so poor that they didn't adhere to my skin for longer than 30 mins.These supplies were essentially unusable.Each month, i wound up buying my own electrodes, and also purchased rechargeable 9-volt batteries (through (b)(6)).I paid approx $(b)(6) for the same amount, if not more, electrodes than this company sent me.I contacted the company on a number of occasions, and left messages.They did not initially call me back.Then they did call me back, and i explained to them that the supplier they were sending were defective.I also told them that i thought they were committing insurance fraud because there was no way that these supplies were worth what they were billing, nor what the insurance was paying for them (since i managed to get the same supplies for substantially less money; i would estimate the same supplies cost approx $(b)(6) a month when all is said and done).I spoke with a person in billing, and a sales mgr.I wrote the company letters in addition to the messages i left complaining about the defective items.I documented some of the conversations, one of which was with an employee named "summer" on (b)(6) 2019.I also sent the company a letter in (b)(6) of 2019.I also spoke with a woman named (b)(6) and a man named (b)(6) (documented in my (b)(6) 2019 letter).I asked them to stop billing me for these products, and to stop sending them.Since they sent me worthless merchandise, and were informed repeatedly, i do not believe that i owe them any money.I fact, when i spoke with (b)(6), she told me that they would correct the claims they sent to (b)(6) (they never did this and have continued to bill me).My physical therapist stopped working with the company because she received numerous complaints of a similar nature from other pts.This company will not leave me alone, and is now threatening to send me to collections.They are committing insurance fraud.If i sent worthless merchandise to a person, and then bill an insurance company, i am committing insurance fraud.I told them so.They've continued to bill me as if there has never been any contact between myself and them, and now jeopardizing my financial reputation.To be clear, i am not complaining about the tens unit itself (for which the company was paid); i am complaining about the quality of the supplies they sent me, and continue to bill me for.(b)(6).Fda safety report id# (b)(4).
 
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Brand Name
TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR
Type of Device
STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
MDR Report Key8992816
MDR Text Key158638813
Report NumberMW5089721
Device Sequence Number1
Product Code GZJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age55 YR
Patient Weight75
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