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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Endocarditis (1834); Fever (1858); Low Blood Pressure/ Hypotension (1914); Insufficiency, Valvular (1926); Unspecified Infection (1930); Sepsis (2067); Thrombus (2101); Chills (2191)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 407652 lead, implanted: (b)(6) 2018. 407645 lead, implanted: (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced infection. The entire system was explanted and later replaced. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The device was returned and analyzed. Returned product analysis was performed and no anomalies were found. 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.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that the patient was admitted with body aches, fever, chills, and diarrhea. Endocarditis was also noted. Blood cultures grew (b)(6). The next day the patient became hypotensive and was admitted to the critical care unit on suspicion of sepsis due to (b)(6). The patient's ejection fraction (ef) decreased to 29%. Computed tomography angiography (cta) showed thrombus or infection lesions on the aortic valve and the leads. The entire system was then explanted, with the patient placed on a temporary pacemaker until permanent replacement days later. The patient had also been given cefazolin two days prior to admission. 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.
 
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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 Key8244787
MDR Text Key132959094
Report Number3004209178-2019-00911
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2019
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2413-2018

Patient Treatment Data
Date Received: 01/14/2019 Patient Sequence Number: 1
Treatment
459878 LEAD
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