MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5386

Device Problem Misconnection (1399)

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

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented for a routine generator change out procedure.During the procedure, the physician was unable to unscrew the atrial set screw from the header of the pacemaker.The physician cut the right atrial lead to remove the device.The device and the lead were both replaced.The patient remained in stable condition.

Manufacturer Narrative

The reported event was confirmed.Analysis of the device found calcified blood filling the atrial setscrew inset/hex cavity.Calcified blood prevented the torque wrench from being fully engaged with the inset, to untighten the setscrew.The blood likely entered through a damaged septum in the form of a hole punched through it, with the torque wrench in the field.

• Brand Name: IDENTITY ADX XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10159361
• MDR Text Key: 195296247
• Report Number: 2017865-2020-07503
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2005
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 0002319676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 90