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

Model Number	5256
Medical Device Problem Codes	Premature Discharge of Battery (1057); Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
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 the pacemaker exhibited backup vvi due to premature battery depletion.V pulse amplitude was noted to be greater than 4 v.The physician believes that the lead wear caused the device to go into backup vvi.Bradycardia was noted.The device was explanted and replaced.The rv lead was made inactive and left in the patient's body.A new rv lead was implanted successfully.The patient was in a stable condition.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• 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: 8242593
• Report Number: 2017865-2019-00591
• Device Sequence Number: 2279275
• Product Code: LWP
• UDI-Device Identifier: 05414734006811
• UDI-Public: 05414734006811
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 5256
• Device Lot Number: 4284088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention