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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3140
Device Problems Failure to Interrogate (1332); No Pacing (3268)
Patient Problem Bradycardia (1751)
Event Date 01/19/2017
Event Type  Injury  
Manufacturer Narrative
Previously reported event date (b)(6) 2017 and first notification date are incorrect. The correct event and first notification dates are (b)(6) 2017.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported when the patient presented to the hospital for a follow-up with bradycardia, the device could not be interrogated by two programmers. There was no source of electromagnetic interference. No pacing was observed with application of a magnet. The pacemaker was explanted and replaced without adverse events.
 
Manufacturer Narrative
The reported inability to communicate with the device was confirmed in the laboratory and was due to premature battery voltage depletion. The premature battery depletion was due to foreign material that was noted across the battery terminals. The cause of the reported field event was a manufacturing anomaly that contaminated the battery terminals.
 
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Brand NameQUADRA ALLURE CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6337785
MDR Text Key106281948
Report Number2938836-2017-15442
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2016
Device Model NumberPM3140
Device Lot NumberA000007607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/16/2017 Patient Sequence Number: 1
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