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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2018
Event Type  malfunction  
Event Description
During an implant procedure, the set screw was unable to be loosened from the hex wrench of the device. The device was explanted and replaced to resolve the event and the patient was stable.
 
Manufacturer Narrative
The reported event of difficulty screwing and securing on the torque wrench on the atrial (a)and left ventricular (lv) leads was confirmed. The analysis found the torque wrench had a fractured shaft. Because of the fracture the torque wrench could not tighten the setscrews. Analysis of the torque wrench found it fractured attempting to loosen a setscrew that required more torque capability than the wrench could handle. The event description only indicates the wrench was being used to tighten the setscrews to connect the leads. How the wrench was being used before this is unknown. The analysis of the crt-p device showed that the a-, lv-, and v-setscrews tightened and loosened normally with no indications of a stuck setscrew or any mechanical problem. The torque wrench was being used beyond its capacity and was expected to fracture. No electrical anomalies were found. The battery voltage is above eri near bol.
 
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Brand NameQUADRA ALLURE MP 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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7742238
MDR Text Key115848330
Report Number2017865-2018-11162
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
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 12/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000060239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2018
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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