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

Model Number	5286
Medical Device Problem Codes	Over-Sensing (1438); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
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
During a routine device exchange, episodes of noise were observed on the right ventricular (rv) channel.The electrical parameters of the rv lead were appropriate when measuring with the pacing system analyzer (psa).The physician noted blood in the header of the device and suspected that this may have caused the noise.The device was successfully replaced.The patient was stable and will continue to be monitored.

• Brand Name: IDENTITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11315583
• Report Number: 2017865-2021-08525
• Device Sequence Number: 16789591
• Product Code: DXY
• UDI-Device Identifier: 05414734006828
• UDI-Public: 05414734006828
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• 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): 02/11/2021

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: 05/31/2012
• Device Model Number: 5286
• Device Catalogue Number: 5286
• Device Lot Number: 3254884
• 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: 01/28/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1