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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUICKFLEX XL LV LEAD; PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC., CRMD QUICKFLEX XL LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1158T/75
Device Problem Failure to Capture (1081)
Patient Problems Muscle Stimulation (1412); Syncope (1610); Dyspnea (1816)
Event Date 08/20/2013
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2013, the patient was evaluated due to syncope.Upon interrogation, the left ventricular lead exhibited loss of capture.No intervention was reported.On (b)(6) 2013, the patient presented in clinic for diaphragmatic stimulation and shortness of breath.The device was reprogrammed.No further information could be obtained.The lead was electively explanted and replaced on (b)(6) 2013 due to an unrelated issue.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
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Brand Name
QUICKFLEX XL LV LEAD
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 Key4583745
MDR Text Key5341940
Report Number2017865-2015-03581
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2014
Device Model Number1158T/75
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/09/2015
Initial Date FDA Received03/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ1483
Patient Sequence Number1
Treatment
(B)(4)
Patient Age39 YR
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