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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 Inappropriate or Unexpected Reset (2959); Operating System Version or Upgrade Problem (2997)
Patient Problem No Patient Involvement (2645)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
Analysis was normal. No anomalies were found.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that the in-box pulse generator reverted to backup operation during a firmware update. The devices was not used.
 
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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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7197979
MDR Text Key115122897
Report Number2017865-2018-00865
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
Report Date 03/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberPM3242
Device Lot NumberP000051821
Other Device ID Number05414734507912
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2017
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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