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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 7425
Device Problems Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins).The reason for call was patient stated that if they do not turn stimulation off after a while, it twists up their back and they can barely walk.Patient noted the stimulation is supposed to be for their legs.Patient noted that where they live has strong electrical pulses and they think the electrical pulses turn the stimulation on.Patient noted one time they had to go to the er because it hurt so bad, and they were able to turn the stimulation off with a magnet.Patient noted that the doctor told them that the manufacturer tried calling the patient several times but gave up because there was no answer, and the patient does not have a voicemail.The patient was redirected to their healthcare provider to further address the issue.
 
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Brand Name
ITREL 3
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key19001423
MDR Text Key338936382
Report Number3004209178-2024-08073
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2006
Device Model Number7425
Device Catalogue Number7425
Was Device Available for Evaluation? No
Date Manufacturer Received03/01/2024
Date Device Manufactured03/07/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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