MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC INTERSTIM NERVE STIMULATOR ; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Hematuria (2558)

Event Date 09/06/2019

Event Type  Injury  

Event Description

Pt has a medtronic interstim device which was implanted by another physician in (b)(6) for bladder pain.However, the device has not been providing any pain relief, and does not appear to be programmed correctly.Medtronic is responsible for providing product support, but i have repeatedly been contacting the reps that serve my region for the last 6 months without any progress in an attempt to have someone come and reprogram the device.The pt has also been contacting them, and he has simply been given the run-around and told that someone will contact him.However, no one has contacted him or myself.This lack of support from the company is very dangerous, and has resulted in increased disability for my pt.He has had to miss days of work as an attorney because of uncontrolled pain.Even the medications that work for him (belbucca and amrix) required me fighting with his insurance to get temporary approval.He has had to pay thousands of dollars out of pocket to obtain these medications while we were waiting for authorization, and still his pain is not controlled.In the era of the opioid epidemic, such lack of oversight and support by medtronic for their pain therapies especially are appalling and dangerous.I believe that he has loin pain hematuria syndrome, a rare orphan disease.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC INTERSTIM NERVE STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 9754025
• MDR Text Key: 181533067
• Report Number: MW5093294
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 35 YR