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

Model Number	5256
Medical Device Problem Codes	Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for a follow-up.The pacemaker was noted to be in backup vvi mode and could not be interrogated.No device intervention was performed.The patient was stable.

• 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: 12434348
• Report Number: 2017865-2021-29882
• Device Sequence Number: 3245378
• Product Code: DXY
• 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: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 02/28/2011
• Device Model Number: 5256
• Device Catalogue Number: 5256
• Device Lot Number: 2918340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1