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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 Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2017
Event Type  malfunction  
Manufacturer Narrative
Analysis revealed the set screw could not be untightened and was dissected to be removed. After separating the set screw from the connector block threads, epoxy debris was observed. The epoxy in the threads likely contributed to the inability to remove the setscrew as it could not be untightened to release the lead.
 
Event Description
During implant, while connecting the leads to the device, the right ventricular (rv) lead was inserted into the atrial connector of the device. The rv lead was attempted to be removed to insert it into the correct place; however, the rv lead could not be disconnected. Three different screw drivers were used with no success. The rv lead was cut and the device was removed. A new rv lead and device were implanted. The patient was stable.
 
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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 Key6665985
MDR Text Key78357366
Report Number2017865-2017-05396
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 06/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2017
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 NumberP000034696
Other Device ID Number05414734509091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2016
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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