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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W4TR01
Device Problem Pacing Problem (1439)
Patient Problem Tachycardia (2095)
Event Date 04/11/2022
Event Type  malfunction  
Event Description
It was reported by the patient that after they had programming changes made to their cardiac resynchronization therapy pacemaker (crt-p), it was making their heart race between 107 and 240 beats per minute.  the device is still in use.  no further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: 459888 lead implanted: (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePERCEPTA QUAD 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 Key14342188
MDR Text Key291311785
Report Number9614453-2022-01338
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169891418
UDI-Public00643169891418
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2019
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/16/2017
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: 05/09/2022 Patient Sequence Number: 1
Treatment
5086MRI52 LEAD, 5086MRI45 LEAD
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