MEDTRONIC INTERSTIM NERVE STIMULATOR 3058

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for MEDTRONIC INTERSTIM NERVE STIMULATOR 3058 manufactured by Medtronic Neuromodulation.

Event Text Entries

[181533067] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093294
• MDR Report Key: 9754025
• Date Received: 2020-02-25
• Date of Report: 2020-02-23
• Date of Event: 2019-09-06
• Date Added to Maude: 2020-02-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDTRONIC INTERSTIM NERVE STIMULATOR
• Generic Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Product Code: KPI
• Date Received: 2020-02-25
• Model Number: 3058
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC NEUROMODULATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2020-02-25