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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 06/19/2017
Event Type  malfunction  
Manufacturer Narrative
The reported field event of backup vvi was confirmed in the laboratory and was due to power on reset with device id corrupted. The id bit corruption affected the devices ability to be recognized when interrogated with merlin programmer. Further analysis could not reproduce the anomalies and the cause of por could not be determined. All other test results were normal.
 
Event Description
It was reported that pulse generator exhibited backup vvi operation in the box. No patient involved in this event.
 
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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 Key6677735
MDR Text Key114567857
Report Number2017865-2017-05755
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
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 11/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberPM3262
Device Lot NumberA000039135
Other Device ID Number05414734509091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2017
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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