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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 Problem Failure to Interrogate (1332)
Patient Problem No Patient Involvement (2645)
Event Date 10/31/2017
Event Type  malfunction  
Manufacturer Narrative
The reported field event of device would not interrogate during the cyber security upgrade could was not confirmed in the laboratory. The device was tested on bench and no anomalies were found.
 
Event Description
It was reported that prior to an implant procedure, the pacemaker would not interrogate during an attempted cybersecurity upgrade attempt. The device was still in the box and 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 Key7016486
MDR Text Key115127205
Report Number2017865-2017-34398
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 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Model NumberPM3242
Device Lot NumberA000022227
Other Device ID Number05414734507912
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2016
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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