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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 (CRT-P)

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MEDTRONIC PUERTO RICO OPERATIONS CO. 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 Bradycardia (1751)
Event Date 11/29/2020
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 since implant of the cardiac resynchronization therapy pacemaker (crt-p) "the heart rate has been at 60. The last few days it was at 59, and a couple of times it went to 58". The patient indicated currently using an external product that measures the heart rate and expressed concern because there has been a sudden change in heart rate. The patient stated that he does not want to go to the doctor, just wondering why this is happening all of a sudden. The patient was referred to the physician. It was further reported that the lower programmed date of the crt-p was 60, and over the last month the patient's heart rate has been as low as 54. The crt-p remains 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 (CRT-P)
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 Key14175689
MDR Text Key290571834
Report Number3004209178-2022-05092
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,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2021
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? No
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2019
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: 04/21/2022 Patient Sequence Number: 1
Treatment
383069 LEAD, 407652 LEAD, 439888 LEAD
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