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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVECTRA CORPORATION ALGOVITA SCS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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NUVECTRA CORPORATION ALGOVITA SCS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 4200
Device Problems Break (1069); Loss of Power (1475); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problems Failure of Implant (1924); Pain (1994); Weakness (2145); Burning Sensation (2146)
Event Date 07/24/2018
Event Type  Injury  
Event Description

I was diagnosed with obturator neuralgia due to previous transvaginal mesh complications. After having numerous treatments, due to my bilateral legs/inner thighs, groin, and buttock pain, my doctor suggested a trial of a new nerve stimulation. On (b)(6) 2018, i had the algovita stimulator generator, and percutaneous leads implanted; exteriorly. My pain level reduced significantly. This device was removed the following week, and i had the permanent version implanted on (b)(6) 2018. Within weeks, i had burning sensations in my lower stomach, and i reported this to my surgeon. On (b)(6) 2018, i went back into surgery, and the doctors discovered that the generator box had dropped. One of the percutaneous leads was also damaged; it was broken off the generator box. They repositioned my generator box to my left flank area, and removed the broken lead. Then, on (b)(6) 2018, i went back to surgery to get the new percutaneous lead replaced. I was discharged from care in (b)(6) 2018. I've had several instances where my programming charger would not connect to the implanted generator, it would not turn on, it would give me numerous error codes or freeze up. Getting nuvectra to assist me, so i could correct these problems, was usually a nightmare. When i had the original permanent implantation, i was told my generator battery implant would have a lifetime of approximately 10 years. Additionally, since i was a case study, i was promised that my problems with this product would be addressed immediately, and i would always have my patient support team. Usually, when i was lucky enough to get a response, nuvectra could walk me through the rebooting process, so i could stimulate my legs. Over the past year, this programmer charger has repeatedly shut down. Then, it completely stopped working, without warning, and nuvectra sent me a new programmer charger on (b)(6) 2020. Now i'm having the same problems with this one, and no one will call me back from nuvectra. Please note, as additional information, i am permanently disabled due to my obturator neuralgia, and when this device shuts down, my legs, inner thighs, groin, and buttocks burn beyond belief. My legs become very weak, and they give out; without warning. Numerous doctor/surgery consult visits. Fda safety report id# (b)(4).

 
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Brand NameALGOVITA SCS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
NUVECTRA CORPORATION
MDR Report Key9915635
MDR Text Key186319494
Report NumberMW5094015
Device Sequence Number1
Product Code LGW
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 03/31/2020
3 DeviceS WERE Involved in the Event: 1   2   3  
1 Patient Was Involved in the Event
Date FDA Received04/01/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number4200
Device Catalogue Number4200
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/01/2020 Patient Sequence Number: 1
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