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

Model Number	5376
Medical Device Problem Codes	Break (1069); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when the patient presented for device change out procedure, the physician was not able to remove the ventricular lead from the device header.It was found to be stuck and was not able to me disconnected.After several attempts, the lead could be removed but the clamping area was broken.The patient was stable.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Additional information: d4, d10, h3, h4, h6.
Additional Manufacturer Narrative
The reported field event was not confirmed in the laboratory.The device was tested on the bench [and using automated testing equipment,] and no anomalies were found.

• Brand Name: IDENTITY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10217517
• Report Number: 2938836-2020-07219
• Device Sequence Number: 3233780
• Product Code: DXY
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/09/2020

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: 12/31/2009
• Device Model Number: 5376
• Device Catalogue Number: 5376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 11/18/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/26/2020; 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1