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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 Under-Sensing (1661)
Patient Problem Atrial Fibrillation (1729)
Event Date 01/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that upon interrogation, the pulse generator exhibited undersensing. Atrial undersensing and atrial pacing delivery occurred simultaneously which was not detected by the pacemaker due to the ventricular blanking period initiated by the atrial pacing pulse. After the biventricular pacing pulse had been delivered, a ventricular tachycardia started. The device was reprogrammed during a follow up.
 
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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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5630681
MDR Text Key44384063
Report Number2017865-2016-02567
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2015
Device Model NumberPM3242
Device Lot Number4592814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2014
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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