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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5056
Device Problems Difficult to Interrogate (1331); No Device Output (1435); Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2014
Event Type  Injury  
Event Description
It was reported that during a routine follow up the pulse generator exhibited backup vvi mode and no output.It was difficult to interrogate the device.The device was explanted and replaced.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.Evaluation description : final analysis confirmed normal battery depletion.
 
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Brand Name
VERITY ADX XL
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 Key3795920
MDR Text Key21876383
Report Number2017865-2014-12414
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P880086
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
Date FDA Received05/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2011
Device Model Number5056
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2009
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;
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