MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5366
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that during a routine generator change, the ventricular set screw would not loosen to allow the removal of the lead.Multiple wrenches were used to attempt to remove the lead by force.When the grommet was removed, the physician noted visual differences in comparison to the atrial setscrew.It was necessary to cap and replace the damaged lead.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Additional Manufacturer Narrative
The reported complaint of could not untighten the ventricular setscrew to remove the lead was confirmed.Analysis found that calcified blood was filling the ventricular setscrew inset.The calcified blood was preventing the wrench from inserting into and engaging the setscrew inset to untighten the setscrew.With the blood removed from the setscrew inset a wrench could then be fully inserted into the inset and engage it and untighten the setscrew to remove the lead.The blood most likely came through damage to the septum in the form of a hole punched through it by the user of the wrench during the implant of the device.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9650585
• Report Number: 2017865-2020-01226
• Device Sequence Number: 379473
• Product Code: DXY
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2008
• Device Model Number: 5366
• Device Catalogue Number: 5366
• Device Lot Number: 2978652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/11/2020; 04/27/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/11/2020; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1