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

Model Number PM2172

Device Problems Difficult to Remove (1528); Fitting Problem (2183); Failure to Disconnect (2541); Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During initial implant, the physician was unable to fully insert the lead to the device header.After several attempts to secure the lead, the lead became stuck in the header and was difficult to remove.The device was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

As received, analysis testing found the a-setscrew was blocking the lead insertion into the a-connector.For analysis testing the setscrew was backed out from blocking the connector port.The test leads could then be fully inserted into the a-connector with normal insertion force.All connector dimensions were within specification.The reported complaint of failure to advance was confirmed.Further analysis found the wrench tip was only being partially inserted into the setscrew inset.The full amount of torque to fully tighten the setscrew cannot be applied with the wrench tip partially inserted in the inset.The reported event of failure to remove lead from header was confirmed.No device anomalies were found.The determined cause of the reported events were procedure related.

• 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: 10679969
• MDR Text Key: 211456267
• Report Number: 2017865-2020-15420
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: PM2172
• Device Catalogue Number: PM2172
• Device Lot Number: P000104409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1