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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI ACCENT SR RF OUS
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ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI ACCENT SR RF OUS Back to Search Results
Model Number PM1210
Device Problem Telemetry Discrepancy (1629)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2012
Event Type  malfunction  
Event Description
It was reported that the pacemaker could not be interrogated.
 
Manufacturer Narrative
This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Final analysis could not verify the complaint.
 
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Brand Name
ACCENT SR RF OUS
Manufacturer (Section D)
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar CA 91342
Manufacturer Contact
cary lawler
15900 valley view ct.
sylmar, CA 91342
8184932621
MDR Report Key4218269
MDR Text Key5038026
Report Number2017865-2014-05303
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2013
Device Model NumberPM1210
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/14/2012
Distributor Facility Aware Date02/14/2012
Device Age6 MO
Event Location Hospital
Date Manufacturer Received02/14/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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