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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC. QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problems Pacing Inadequately (1442); High Capture Threshold (3266)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2017
Event Type  malfunction  
Manufacturer Narrative
Visual examination and mechanical testing revealed normal device characteristics. Output monitoring and capture tests indicated no anomalies. The device head was evaluated where no defects were identified that could contribute to the complaint of inadequate capture. The results of the investigation concluded the analysis of the device was normal with no anomalies found. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
During the implant procedure, an increase in the left ventricular threshold and inadequate pacing on the right ventricular lead were noted after the leads were connected to the pacemaker. The device was explanted and replaced and all of the electrical measurement were normal and within range. The patient was in stable condition.
 
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Brand NameQUADRA ALLURE MP RF CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key6995041
MDR Text Key107512794
Report Number2017865-2017-33286
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
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 NumberP000044352
Other Device ID Number05414734509091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2017
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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