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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL PERCEPTA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR04
Device Problems Failure to Capture (1081); Mechanical Problem (1384)
Patient Problem Dizziness (2194)
Event Date 02/21/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical product: 5076-58 lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was presyncopal. The right ventricular (rv) lead was found to have no capture at high output four days after implant of a new device. The patient was brought back for a device revision. When inspecting the header, the lead appeared to be fully inserted. The physician decided to replace the lead as the patient was 100% pacing dependent. The new lead had good numbers when tested through the analyzer. When the lead was inserted into the device it was not capturing as maximum output. The physician recalled that the rv setscrew had felt a little tight during the implant. The device was then explanted and a new device was implanted. The new rv lead was inserted and testing revealed good parameters. The new rv lead and device remain 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 indicated the impedance of the atrial pacing lead was beyond the expected upper range. Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. Returned product analysis 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 NamePERCEPTA 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 Key8433749
MDR Text Key139236262
Report Number9614453-2019-00854
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2019
Device Model NumberW4TR04
Device Catalogue NumberW4TR04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2018
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: 03/19/2019 Patient Sequence Number: 1
Treatment
429888 LEAD
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