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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUARTET; PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC., CRMD QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/75
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Cardiac Arrest (1762); Death (1802)
Event Date 11/24/2014
Event Type  Death  
Event Description
It was reported that the patient experienced syncope at home five days post implant.Emergency personnel initiated external shocks and resuscitation efforts.The patient later expired at the hospital.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
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Brand Name
QUARTET
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jennie hamel
15900 valley view court
sylmar, CA 91342
8184933462
MDR Report Key4354365
MDR Text Key5172732
Report Number2017865-2014-19429
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/29/2016
Device Model Number1458Q/75
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/24/2014
Initial Date FDA Received12/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CD3371,7123227,1999,(B)(4),7120,(B)(4)
Patient Outcome(s) Death;
Patient Age86 YR
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