MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT PROCLAIM DRG NEUROSTIMULATION SYSTEM; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Model Number 3664

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 09/27/2021

Event Type  malfunction  

Event Description

Extreme pain in leg; on (b)(6) 2021, and abbott drg neuro stimulator was implanted to control crps in my right leg.An (b)(6) controller was provided and i was instructed that the device could be controlled via an (b)(6) as well.The device is controlled by the patient (me) via the abbott/st.Jude patient controller app on either the (b)(6).On (b)(6) 2021, after upgrading my (b)(6), the app stopped working on both devices.The app will try to open and then just disappear.The only way to get the app to work on my (b)(6) is to delete it from the device and re-download the app.Then you have to re-pair the app to the implant using the magnet.Once it recognizes your device, you can then control the settings again.The app on the (b)(6) no longer works, even after re downloading it.It will not pair with my implanted device and just gives an error.I've had to continue this delete/re download of the app process daily in order to control my implanted device.It's extremely dangerous to not be able to control my device, especially since it's implanted to control pain in my driving (right) leg.Fda safety report id# (b)(4).

• Brand Name: ABBOTT PROCLAIM DRG NEUROSTIMULATION SYSTEM
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 12648431
• MDR Text Key: 277144748
• Report Number: MW5104671
• Device Sequence Number: 1
• Product Code: PMP
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3664
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR