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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC EUROPE SARL AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMB2D1
Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 04/26/2024
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 the patient received an inappropriate shock from the cardiac resynchronization therapy defibrillator (crt-d) while a cream warming device was being used during a massage.It was noted that prior to the shock the interference was present an caused two lead different very low near zero lead impedance measurements.The crt-d remains in use. no further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory observed noise on the electrogram waveforms.Analysis of the device memory indicated the left ventricular pacing impedance was below the expected lower range.Analysis of the device memory indicated the right ventricular pacing impedance was below the expected lower range.Analysis of the device memory indicated emi.Analysis of the device memory indicated unexpected delivery of ventricular tachyarrhythmia therapy.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
Additional information received noted noise was observed on recorded episodes and oversensing.It was noted that the variation in rv lead impedance and the oversensing caused a lead integrity alert (lia).
 
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.
 
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Brand Name
AMPLIA MRI CRT-D SURESCAN
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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 Key19209703
MDR Text Key341593680
Report Number9614453-2024-01698
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P010031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/28/2021
Device Model NumberDTMB2D1
Device Catalogue NumberDTMB2D1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/06/2020
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 Outcome(s) Life Threatening;
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