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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SERENA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL SERENA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR05
Device Problems High impedance (1291); Mechanical Problem (1384); Misconnection (1399)
Patient Problem Exit Block (2628)
Event Date 10/10/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that shortly after cardiac resynchronization therapy pacemaker (crt-p) implant, high right ventricular pacing impedance with exit block was observed and a connection issue was suspected. The right ventricular (rv) lead was able to be pulled out of the crt-p without resistance. The lead was disconnected and measured and electrical values were within normal limits. The lead was reinserted and clicking of the setscrew was audible as the screw was tightened; however the lead could still be removed without resistance. The crt-p was explanted and replaced as there was no lead issue. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSERENA QUAD CRTP
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8130725
MDR Text Key129324544
Report Number9614453-2018-04269
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
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 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2019
Device Model NumberW4TR05
Device Catalogue NumberW4TR05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2018
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: 12/04/2018 Patient Sequence Number: 1
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