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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3242
Device Problems Telemetry Discrepancy (1629); Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during pre-implant in box interrogation in (b)(6) 2016, the pulse generator exhibited radio frequency telemetry anomaly despite using multiple programmer. The device was checked again six weeks later and exhibited same anomaly. The device was not used.
 
Manufacturer Narrative
Final analysis found the pulse generator could not establish communication via radio frequency antenna due to excessive high power usage. After product code download, device was able to be able to be interrogated with both inductive wand and radio frequency antenna.
 
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Brand NameALLURE QUADRA RF CRT-P
Type of DeviceIMPLANTABLE 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 Key5725860
MDR Text Key47458325
Report Number2017865-2016-03715
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Model NumberPM3242
Device Lot NumberA000010030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
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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