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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 Problem Thrombosis (2100)
Event Date 05/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 439888 lead, implanted: (b)(6) 2019. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that post implant procedure, the patient developed a left subclavian vein thrombosis due to the implant of the cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead. Medication was administered, and the device and lead remain in use. The patient is a participant in the post approval clinical surveillance product surveillance registry. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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
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 Key8927653
MDR Text Key155474780
Report Number3004209178-2019-16280
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,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2020
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 Received08/26/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/10/2018
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: 08/23/2019 Patient Sequence Number: 1
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