MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL II; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7424

Device Problems Intermittent Continuity (1121); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding an implantable neurostimulator (ins).The reason for call was caller stated that patient uses a magnet to turn ins off and reported whenever patient goes near a microwave, their ins turns off and on.Caller stated patient also reported when they go into jewelry stores, they set the alarms off, their device flickers and their arm "goes weird".Caller stated patient would like to have system removed.The caller was asked if patient is still using the system since they are still using a magnet to turn ins off and caller agreed.Troubleshooting was not required.The issue was not resolved through troubleshooting.The caller was redirected to tss reviewed to have patient contact ps for physician listings and that technology has changed so that with a more current system, issues the patient reported should be less likely.Surgical robot.

• Brand Name: ITREL II
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11474162
• MDR Text Key: 244549983
• Report Number: 2182207-2021-00433
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7424
• Device Catalogue Number: 7424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1