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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Patient Involvement (2645)
Event Date 08/28/2017
Event Type  malfunction  
Manufacturer Narrative
The reported field event of backup vvi (bvvi) was confirmed in the laboratory consistent with effects of telemetry interruption. The device was tested on the bench and analysis performed after reloading product code indicated normal device characteristics. The cause of the bvvi was due to hardware, and this is consistent with effects of telemetry interruption, which was caused by the user during the firmware upgrade.
 
Event Description
It was reported that the device was found in backup operation. Multiple attempts at performing a firmware upgrade on the pacemaker failed as the device was still in the box. After several failed attempts, the device went into backup operation. The device was returned for further analysis.
 
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Brand NameQUADRA ALLURE MP 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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6925827
MDR Text Key115123053
Report Number2017865-2017-31821
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Model NumberPM3262
Device Lot NumberA000028215
Other Device ID Number05414734509091
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2016
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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