MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3562

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2020-06317.During an implant procedure, the left ventricular (lv) lead was being tested and the connector sleeve from the box was unable to fit on the lv lead.A new connector sleeve was opened, but was still unable to fit on the lv lead.The lv lead was attempted to be inserted into the header of the device, but was not able to be connected successfully.The set screw was unscrewed slightly, but the lv lead was still unable to be connected to the header.A new lv lead was opened and the connector sleeve was able to successfully fit on the lead.The new lv lead was attempted to be inserted into the device, but was not able to be connected successfully.A new device was opened and the second lv lead was able to be inserted into the device successfully to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Additional information: d10, h3, and h6.The reported complaint of failure to insert the left ventricular (lv) lead into the lv-connector was confirmed.Analysis testing revealed the lv-set screw was blocking the lead from being inserted into the lv-connector.Furthermore, analysis revealed that the lv-set screw was manipulated in the field.For analysis testing, the set screw was backed out from blocking the connector port.Is-4 test leads could then be fully inserted into the lv-connector with normal insertion force.All connector dimensions were within specification and no device anomalies were revealed.This can be considered a user-related anomaly since the user manual now states to retract the set screws in the device connector so the pacing lead terminal pins can be fully inserted.It also states that the user may make up to two rotations of the torque wrench to retract the set screw, which would have backed the set screw out from blocking the insertion of the lead.The device was revealed to be electrically normal.The battery voltage is above elective replacement indicator (eri) and is near beginning of life (bol).

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10069831
• MDR Text Key: 191398544
• Report Number: 2017865-2020-06314
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000089741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUARTET LEAD DOUBLE BEND, 86 CM; QUARTET LEAD DOUBLE BEND, 86 CM