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

Model Number PM2272

Device Problems Misconnection (1399); Separation Failure (2547)

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

Event Date 07/08/2020

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: 2017865-2020-09616.During a clinic follow-up, a loss of capture and episodes of oversensing were observed on the right atrial (ra) lead.Diagnostic imaging was performed and revealed a dislodgement of the ra lead.During a replacement procedure, the ra lead was unable to be removed from the device header due to the torque wrench being too tight.Both the ra lead and device were explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported event of unable to loosen the atrial setscrew in order to disconnect the atrial lead was confirmed.The analysis found that the setscrew was unable to be untightened and had to be removed by machining.Epoxy was confirmed to be the substance found in the atrial connector block threads, which caused the setscrew to be stuck in place and unable to be untightened by the wrenches.Corrective actions have been issued to address epoxy material in the device header to prevent reoccurrence.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10333602
• MDR Text Key: 200644387
• Report Number: 2017865-2020-09615
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000062487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS; TENDRIL STS