MAUDE Adverse Event Report: IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5386
Medical Device Problem Codes	Pacemaker Found in Back-Up Mode (1440); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the symptomatic patient presented with palpitations in clinic during follow-up with backup vvi.It was noted that the device had reach eri.Download was not performed due to a low battery status.The patient has not decided when to have the device removed, as patient doesn't need the pacemaker.It was later noted that the lead was fractured with high thresholds and high impedance.Device is still in backup vvi.Nothing will be done to the lead as the patient is not using the pacemaker.No replacement has been scheduled.Patient condition was stable.Related manufacturer reference number: 2017865-2022-13669.

• Brand Name: IDENTITY ADX XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14880622
• Report Number: 2017865-2022-13668
• Device Sequence Number: 5089389
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: 11/30/2006
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 0002318904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ISOFLEX
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 94 KG