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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 High impedance (1291); No Pacing (3268)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2017
Event Type  malfunction  
Manufacturer Narrative
The field complaint of no output could not be confirmed. Monitoring of the device output and capture test found no output anomalies. Evaluation of the device header found no defect that could contribute to the reported incident. Further analysis revealed the device was above eri and exhibited normal characteristics.
 
Event Description
During the implant procedure, there was no pacing and elevated impedance when the device was connected to the right ventricular lead. The physician elected to use a different device, which was implanted without issue. The patient's condition was stable following the procedure.
 
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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 Key6660600
MDR Text Key113659082
Report Number2017865-2017-05438
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeFR
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 08/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model NumberPM3262
Device Lot NumberP000041847
Other Device ID Number05414734509091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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