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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 Problem Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 12/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
During the implant procedure, there was an audible sound when the physician squeezed and applied pressure to the device. The device did not make contact with the patient. The device was replaced and the patient was stable.
 
Manufacturer Narrative
Additional information: no conclusion code available. Inspection of the device can confirmed that it was within the acceptable guidelines. Thermal and mechanical testing of the device indicated that the pacer exhibited normal device characteristics. A crude leak test was performed and no leakage was detected on the can. The device was cut open and the bumper tape and moisture getter were both in place. The audible noise was most likely due to slight flexing from the can when pressure was applied. This did not affect the form, fit and function of the device and would not lead to any clinical risk.
 
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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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6236231
MDR Text Key64663352
Report Number2017865-2017-00187
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P030035
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 12/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Model NumberPM3262
Device Lot NumberP000034494
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2016
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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