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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

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MEDTRONIC EUROPE SARL; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number DVEX3E4
Device Problem Electromagnetic Interference (1194)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
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
It was reported that episodes of oversensing due to transient small r waves was determined to be electromagnetic interference on the extravascular implantable cardioverter defibrillator (ev-icd).The device remains in use. no patient complications have been reported as a result of this event.
 
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Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ  1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ   1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key19165665
MDR Text Key341613410
Report Number9614453-2024-01592
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/14/2021
Device Model NumberDVEX3E4
Device Catalogue NumberDVEX3E4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/02/2024
Date Device Manufactured10/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EV420163
Patient Age45 YR
Patient SexMale
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