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 09/26/2018

Event Type  malfunction  

Event Description

During an elective device upgrade, the tip of the right ventricular (rv) lead was accidentally cut off while opening the device pocket.While trying to replace the rv lead, the set screw of the rv lead was unable to be loosened from the device header.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported event of difficulty untightening the right ventricular (rv)-setscrew to remove the lead was confirmed.The analysis found the rv-setscrew was firmly stuck in the connector block and required destructive methods to separate it from the device connector.Analysis performed using scanning electron microscope confirmed the foreign material found in the connector block threads to be epoxy, which caused the setscrew to get stuck.When the setscrew was tightened on the leads during the implant procedure the epoxy in the threads caused the setscrew to be locked in place which prevented removal of the lead.As a result of these findings, abbott is performing further investigation.No electrical anomalies were found.The battery voltage is above the elective replacement indicator (eri) near beginning of life (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: 7940098
• MDR Text Key: 123433260
• Report Number: 2017865-2018-14907
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000058597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• 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