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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problems High impedance (1291); Mechanical Problem (1384); Connection Problem (2900)
Patient Problem Hematoma (1884)
Event Date 08/22/2017
Event Type  Injury  
Manufacturer Narrative
The reported inability to loosen/tighten the left ventricular set screw was confirmed in the laboratory. Visual inspection identified septum debris material inside the left ventricular screw hex cavity. This material prevented full insertion of the torque driver in the hex cavity and resulted in difficulty loosening/tightening the set screw. After septum debris were removed from setscrew inset, the lead was able to be tightened securely onto the connectors.
 
Event Description
It was reported that the patient during a post-implant discharge check, it was noted that the patient had developed hematoma and high impedance were observed on the left ventricular lead. The doctor was informed and they opened the pocket to perform a tug-test and hematoma evacuation. During the tug test the lead came right out of the connector. Due to a bad set-screw, the patient's pacemaker was exchanged for a new pulse generator. The patient was stable throughout the replacement 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.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6881043
MDR Text Key107115034
Report Number2017865-2017-31678
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberPM3262
Device Lot NumberA000043239
Other Device ID Number05414734509091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2017 Patient Sequence Number: 1
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