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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD IDENTITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD IDENTITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5180
Device Problem Difficult to Interrogate (1331)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2014
Event Type  Injury  
Event Description
It was reported that an asymptomatic patient presented for routine follow-up.The pulse generator could not be fully interrogated.Battery data was not displayed.The device was explanted and replaced on (b)(6) 2014.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.Device evaluation anticipated, but not yet begun.
 
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Brand Name
IDENTITY ADX SR
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 Key3665330
MDR Text Key4341728
Report Number2017865-2014-10784
Device Sequence Number1
Product Code LWP
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,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2005
Device Model Number5180
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2004
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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