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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR01
Device Problem Pacing Problem (1439)
Patient Problem Insufficient Information (4580)
Event Date 01/20/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported by the patient that they were doing exercises at cardiac rehab when they were told to stop because "something was off" on their electrocardiogram (ecg) and the cardiac resynchronization therapy pacemaker (crt-p) was not providing the necessary pacing therapy. The device is still in use. No further patient complications have been reported as a result of this event.
 
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Brand NamePERCEPTA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11279032
MDR Text Key232551615
Report Number3004209178-2021-01960
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169735644
UDI-Public00643169735644
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 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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