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

Model Number	5256
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	04/25/2019
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.Further information was requested but not received.
Event or Problem Description
It was reported that during a routine generator change, the pacemaker stopped pacing due to use of electrocautery.The patient experienced bradycardia.The device was explanted and replaced.Patient was stable.
Additional Manufacturer Narrative
The device was received in backup mode and device image analysis indicates backup mode was caused by code corruption by exposing the pacer to electrosurgical device during the explant procedure.Further testing performed indicated the device performed normal with normal functionality.Longevity assessment was performed, and the device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: VERITY ADX XL
• 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: 8613584
• Report Number: 2017865-2019-08231
• Device Sequence Number: 2523021
• Product Code: LWP
• UDI-Device Identifier: 05414734006811
• UDI-Public: 05414734006811
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 08/06/2019

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: 05/31/2006
• Device Model Number: 5256
• Device Lot Number: 0002331921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR