MAUDE Adverse Event Report: ABBOTT ENDURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2172

Device Problem Fitting Problem (2183)

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

Event Date 07/13/2020

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: 2017865-2020-10244.During an implant procedure, an increase in the pacing impedance was observed on the ra lead.Upon investigation, it was observed that the ra lead was unable to be fully inserted into the atrial plug of the device, so the device was explanted and replaced.The ra lead was successfully connected to the new device to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported complaint of the atrial lead would not fully insert into the atrial-connector was not confirmed.Analysis testing did not reveal any obstructions to lead insertion into the atrial-connector port.All connector dimensions were within specification.Is-1 test leads were able to be fully inserted into the connectors with normal insertion force.The analysis did not reveal any device anomalies.There were indications that the setscrew had been manipulated in the field, but as received the setscrew was not blocking the connector port.The device passed all electrical testing.The device read 500 ohm when testing the impedance and loads normally.The device had normal device characteristics.

• Brand Name: ENDURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10350212
• MDR Text Key: 201209472
• Report Number: 2017865-2020-10242
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: 05414734509602
• Combination Product (y/n): N
• PMA/PMN Number: P140033
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: PM2172
• Device Catalogue Number: PM2172
• Device Lot Number: P000095655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS; TENDRIL STS