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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ALLURE QUADRA RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ALLURE QUADRA RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3242
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Connective Tissue Disease (1786); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Confusion/ Disorientation (2553)
Event Date 09/29/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced confusion, pleural effusion, shortness of breath, hypotensive episode and symptoms related to heart failure during a post-implant follow-up. No further information is available.
 
Event Description
Additional information received indicated that the adverse event was resolved without sequelae. The patient was discharged on (b)(6) 2016, and will be followed up normally.
 
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Brand NameALLURE QUADRA RF CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6076590
MDR Text Key59070650
Report Number2938836-2016-13715
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Model NumberPM3242
Device Lot NumberA000020314
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 Received11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2016
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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