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

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.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: IMPLANTABLE 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 Key: 7742238
• MDR Text Key: 115848330
• Report Number: 2017865-2018-11162
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000060239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1