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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION ITREL II STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
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.
 
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Brand NameITREL II
Type of DeviceSTIMULATOR, 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 Key11474162
MDR Text Key244549983
Report Number2182207-2021-00433
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7424
Device Catalogue Number7424
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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