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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 Problem Pacing Problem (1439)
Patient Problem Cardiac Arrest (1762)
Event Date 11/19/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a device change out procedure the cardiac resynchronization therapy pacemaker (crt-p) did not pace on the left ventricular lead and the patient went asystolic. Different programming configurations were tried but the device would not pace in the lv. It was noted that through the analyzer the device functioned as expected. The device was not implanted and the decision was made to upgrade the device to at cardiac resynchronization therapy defibrillator (crt-d).  no further patient complications have been reported as a result of this event.
 
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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 Key12863843
MDR Text Key281175861
Report Number9614453-2021-04403
Device Sequence Number1
Product Code NKE
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,Followup
Report Date 12/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2021
Device Model NumberW1TR01
Device Catalogue NumberW1TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2020
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: 11/23/2021 Patient Sequence Number: 1
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