MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5357 M/S VERITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5357M/S
Medical Device Problem Codes	Failure to Interrogate (1332); Pacing Intermittently (1443)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
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 patient presented in the emergency room and was intermittently pacing.When attempting to interrogate the device, an error message appeared on the programmer.It was suspected that the device was at end of life, causing the intermittent pacing.The device was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of pacing intermittently was confirmed.As-received, the device had no output and no telemetry due to battery voltage at end-of-life level.Analysis performed, after installing a new battery and reloading product code, indicated that the device exhibited normal device characteristics with no anomalies.Longevity assessment was performed based on field settings, the implant duration exceeded the device¿s projected longevity and device is considered normal battery depletion.

• Brand Name: 5357 M/S VERITY ADX 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: 10814704
• Report Number: 2017865-2020-17450
• Device Sequence Number: 4011562
• Product Code: DXY
• UDI-Device Identifier: 05414734006842
• UDI-Public: 05414734006842
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 09/30/2012
• Device Model Number: 5357M/S
• Device Catalogue Number: 5357M/S
• Device Lot Number: 3343667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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