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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SERENA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL SERENA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR05
Device Problem Pacing Problem (1439)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) had missed ventricle pacing beats a few days after the patient underwent an atrioventricular node ablation. Reprogramming was done, and the device remains in use. No 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 was performed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSERENA CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9298683
MDR Text Key167794740
Report Number9614453-2019-03789
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2018
Device Model NumberW1TR05
Device Catalogue NumberW1TR05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/08/2019 Patient Sequence Number: 1
Treatment
5076-58 LEAD, 5076-52 LEAD, 429688 LEAD
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