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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5386
Device Problems Failure to Capture (1081); Pacemaker Found in Back-Up Mode (1440); Telemetry Discrepancy (1629)
Patient Problem Cardiac Arrest (1762)
Event Date 12/17/2013
Event Type  Injury  
Event Description
It was reported that the patient was presented in the emergency room with asystole and loss of capture.The pulse generator was found in backup vvi mode and telemetry was unsuccessful.The patient was stabilized with external pacing patches.The device was explanted and replaced.
 
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Brand Name
IDENTITY ADX XL DR
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
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
cary lawler
15900 valley view court
sylmar, CA 91342
8184932621
MDR Report Key3618534
MDR Text Key16687148
Report Number2017865-2014-09660
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2006
Device Model Number5386
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
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