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	07/12/2019
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.Further information was requested but not received.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 generator replacement procedure, the physician was unable to remove the set screw from a lead and suspected the screw to be missing or 'threaded'.The lead was cut and a new device was successfully implanted.The patient was noted to be unharmed and their condition remains well.
Additional Manufacturer Narrative
The reported complaint of the a-setscrew could not be untightened to remove the lead was confirmed.The device was tested on the bench and analysis found that calcified blood was filling the a-setscrew inset preventing the wrench from engaging the setscrew inset to untighten the setscrew.The blood was removed from the setscrew inset and the setscrew was able to be untighten to remove the lead.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.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8819897
• Report Number: 2017865-2019-11219
• Device Sequence Number: 3109669
• 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 Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 07/31/2008
• Device Model Number: 5366
• Device Lot Number: 2977874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1