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

Model Number PM2272

Device Problem Separation Failure (2547)

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

Event Date 03/10/2020

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 a lead replacement procedure, the header of the device would not separate from the right ventricular (rv) lead.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

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

Event Description

During a lead replacement procedure, the header of the device would not separate from the atrial lead.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported complaint of unable to untighten the atrial (a) -setscrew to remove the lead was confirmed.Analysis found the a-setscrew had been stripped by the user of the torque wrench in the field.The setscrew inset had been completely stripped out so that the torque wrench could no longer engage it to untighten the setscrew.No device anomalies were found to cause the stripping of the setscrew.The stripped setscrew is related to the user¿s use of the torque wrench.

• 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: 9849039
• MDR Text Key: 183939369
• Report Number: 2017865-2020-03614
• 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,Followup
• Report Date: 06/11/2020

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: 07/31/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000097590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 05/11/2020; 06/08/2020
• Supplement Dates FDA Received: 05/14/2020; 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR