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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3222
Device Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Patient Involvement (2645)
Event Date 10/04/2017
Event Type  malfunction  
Manufacturer Narrative
The reported field event of backup vvi was not confirmed in the laboratory. The device was tested on the bench, and using automated testing equipment, no anomalies were found.
 
Event Description
It was reported that prior to implant procedure, the pulse generator exhibited backup vvi operation. It was noted that a cybersecurity upgrade was performed successfully. The device was not used. No further information was reported.
 
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Brand NameALLURE RF
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 Key6967341
MDR Text Key102800457
Report Number2017865-2017-33452
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 01/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Model NumberPM3222
Device Lot NumberA000034748
Other Device ID Number05414734507905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2017
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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