MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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	06/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the set screw was unable to be loosened from the header.The device was explanted and replaced to resolve the event and the patient was stable.
Additional Manufacturer Narrative
The reported complaint of difficulty removing the ventricular lead from the device header due to a setscrew issue was confirmed.Analysis of the device header identified calcified blood in the ventricular (v)-setscrew inset.The calcified blood was limiting wrench insertion and preventing the wrench from engaging the setscrew inset walls which is necessary to untighten the setscrew.The calcified blood was removed from the setscrew inset.A wrench could then be inserted into the inset and the setscrew untightened.The lead could now be removed from the device.The blood most likely came through damage to the septum in the form of a hole punched through it.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7685552
• Report Number: 2017865-2018-10251
• Device Sequence Number: 1316030
• Product Code: LWP
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 12/31/2005
• Device Model Number: 5366
• Device Lot Number: 3018452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1