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

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).

• Brand Name: ALGOVITA SCS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NUVECTRA CORPORATION
• MDR Report Key: 9915635
• MDR Text Key: 186319494
• Report Number: MW5094015
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4200
• Device Catalogue Number: 4200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 76