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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL PERCEPTA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W1TR01
Device Problems Pacing Problem (1439); Capturing Problem (2891)
Patient Problems Chest Pain (1776); Tachycardia (2095)
Event Date 04/05/2022
Event Type  Injury  
Event Description
It was reported that an atrial tachycardia was induced during in-office threshold testing of the left ventricular lead. The patient reportedly had a history of atrial tachycardia being induced during device interrogations. The patient could feel it but tolerated it well. The patient confirmed having felt this sensation at least twice a day for as long as they could remember. The tachycardia spontaneously terminated but recurred when threshold testing was attempted again. It was determined by a healthcare professional that this was a form of pacemaker-mediated tachycardia induced with left ventricle (lv)-only pacing. These episodes were recorded by thecardiac resynchronization therapy pacemaker (crt-p) as atrial tachycardia/atrial fibrillation (at/af). It was noted that at/af episodes would occur at times when the device feature which monitors pacing thresholds may have just run. When the patient was left ventricle (lv)-only pacing, the signal was delayed on the right atrial (ra) channel, falling outside the blanking and refractory periods, and was oversensed. As the at/af episodes were likely being triggered by lv threshold testing, the device feature which monitors pacing thresholds was turned off. It was also noted that the patient had experienced some chest pain during times of peak activity. An exercise stress test suggested the patient might have been feeling dropped beats once the crt-p had reached the upper rate limit. The upper tracking rate was increased which improved the patient¿s symptom. The crt-p and ra lead remain in use. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: 4968-25 lead implanted: (b)(6) 2009. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePERCEPTA CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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 Key14315387
MDR Text Key291312798
Report Number9614453-2022-01305
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169891401
UDI-Public00643169891401
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2022
Device Model NumberW1TR01
Device Catalogue NumberW1TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/19/2020
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: 05/07/2022 Patient Sequence Number: 1
Treatment
511211 LEAD, 4965-35 LEAD
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