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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
The reported event of backup operation was confirmed. Analysis of the device image revealed telemetry logical channel open authentication failure from telemetry interruption, which resulted in the reported issue on backup operation. Electrical testing revealed normal device characteristics with battery voltage near beginning of life (bol).
 
Event Description
Before an implant procedure, the device was noted in backup vvi mode. The device was not implanted and the patient was stable.
 
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Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7142402
MDR Text Key115218231
Report Number2017865-2017-36109
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000038478
Other Device ID Number05414734510097
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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