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

Model Number	5376
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
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.
Event or Problem Description
It was reported that during generator change procedure, the set screws were unable to be loosened.The physician removed the silicon grommets and cleaned the hex slots, eventually the right atrial lead could be removed but the right ventricular lead could not be removed.The device was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported event of v-setscrew could not be untightened to remove the lead and problems untightening the a-setscrew was confirmed.Analysis found calcified blood in the v-setscrew inset and calcified blood covering the a-connector.The calcified blood was preventing the wrench from engaging the setscrew inset to untighten the setscrew.The blood most likely came through damage to the septum in the form of a hole punched through it.

• Brand Name: IDENTITY XL DR
• 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: 9291182
• Report Number: 2017865-2019-16087
• Device Sequence Number: 2107226
• Product Code: DXY
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• 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: 2004
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 10/31/2005
• Device Model Number: 5376
• Device Lot Number: 0002294500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 88