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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 Appropriate Term/Code Not Available (3191)
Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient presented for a magnetic resonance imaging (mri) scan and the cardiac resynchronization therapy pacemaker (crt-p) was programmed to mri-safe pacing mode prior to the scan. The patient rhythm at the time of the interrogation prior to the reprogramming was atrial sense/left ventricular only paced at 82 beats per minute. The patient was moved to the scanning room; approximately seven minutes later, a supra ventricular tachycardia (svt) or atrial fibrillation (af) with rapid ventricular response was observed on the monitor. The patient was removed from the scan room and connected to a programmer/electrocardiogram (ecg) cables and re-interrogated. Af with rvr was confirmed. Mri-safe mode was programmed off and the device was programmed to the previous settings. The patient's cardiologist was contacted and arrived at the mri department to further diagnose and treat the patient. Reactive anti-tachycardia pacing was programmed on, an intravenous (iv) was started when the patient developed low blood pressure; it was decided to give the patient a neosynephrine ivp and transfer the patient to the emergency room for further treatment. It was noted there was no previous history of af for the patient prior to the event. 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
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 Key9264876
MDR Text Key165945614
Report Number3004209178-2019-20846
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/27/2017
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: 11/01/2019 Patient Sequence Number: 1
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