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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problems Over-Sensing (1438); Device Operates Differently Than Expected (2913)
Patient Problems Atrial Fibrillation (1729); No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
New information received notes that the patient presented in the hospital with heart failure symptoms. Interrogation of the device showed the patient experienced atrial fibrillation (af) rhythm. Physician performed cardioversion to convert the patient's af rhythm back to normal sinus rhythm. The patient will be brought back in the clinic for further programming changes. The physician will continue monitoring the process. The patient is currently asymptomatic.
 
Event Description
It was reported that short duration of auto mode switch (ams) was noted due to noise oversensing on ra channel. The patient did not have a history of atrial fibrillation. The data from merlin@home transmission suggested that short duration of ams events might be an internal measurement causing the oversensed behavior. Programming changes were recommended. The patient was not symptomatic due to the noise and will be scheduled for follow-up and programming changes.
 
Event Description
New information received notes that the recommended programming changes were made to resolve the issue. There were no adverse consequences to the patient.
 
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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-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6637792
MDR Text Key109498255
Report Number2938836-2017-29020
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Model NumberPM3262
Device Lot NumberA000029525
Other Device ID Number05414734509091
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 Received05/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2016
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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