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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AMPLIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC EUROPE SARL AMPLIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMB2QQ
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Patient Problems Tachycardia (2095); Shock from Patient Lead(s) (3162)
Event Date 04/25/2024
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 experienced tachycardia received an inappropriate shock from the cardiac resynchronization therapy defibrillator (crt-d).The crt-d remains in use. no further patient complications have been reported as a result of this event.
 
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 further reported that an atrial event occurred that generated an atrial tachycardia which was fast conducted to the ventricles.The device was reprogrammed.
 
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 was performed and no anomalies were found.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 that during left ventricular (lv) lead only pacing a retrograde atrial event occurred which starts an atrial tachycardia.This supra ventricular tachycardia (svt) is conducted fast to the ventricles, which initiated the inappropriate therapy.The physician noted that this was observed only during lv only pacing.
 
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Brand Name
AMPLIA MRI QUAD 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 Key19209389
MDR Text Key341471929
Report Number9614453-2024-01696
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeFI
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 05/02/2024
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 Model NumberDTMB2QQ
Device Catalogue NumberDTMB2QQ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/21/2023
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) Required Intervention; Life Threatening;
Patient Age60 YR
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