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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5386
Device Problem Difficult to Interrogate (1331)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient presented to the clinic for routine follow-up.The pulse generator was difficult to interrogate.It was noted that the device had reached eri on (b)(6) 2016.The device was explanted and replaced on 4/13/16.There were no adverse consequences to the patient.
 
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Brand Name
IDENTITY ADX XL DR
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5620398
MDR Text Key44054805
Report Number2017865-2016-02583
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2007
Device Model Number5386
Device Lot Number0002185001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2006
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 Age80 YR
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