MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) IDENTITY ADX SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5180
Medical Device Problem Codes	Pacemaker Found in Back-Up Mode (1440); No Pacing (3268)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon interrogation, the device was found to have gone into back up vvi mode.The device failed to provide impulses intermittently.The device was explanted.The patient was stable.
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.
Additional Manufacturer Narrative
The reported events of backup operation and pacing anomaly were confirmed.The device was received with no output, no telemetry and battery at end of service.The device image could not be saved due to lack of telemetry and it was requested to the field, but it was not available.The original battery was replaced after cutting open the device case and the product code was downloaded successfully.The device was tested under nominal conditions with results indicating normal functionality.The pacer was monitored for several days, and results indicated performance was normal.Additionally, evaluation of the output pacing found all parameter within normal range.The backup operation observed in the field is consistent with low battery voltage fluctuation.The backup operation observed in the field is consistent with low battery voltage fluctuation.Total projected longevity based on nominal conditions it is considered normal battery depletion.

• Brand Name: IDENTITY ADX SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9380384
• Report Number: 2938836-2019-16703
• Device Sequence Number: 3091123
• Product Code: DXY
• UDI-Device Identifier: 05414734006804
• UDI-Public: 05414734006804
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2021

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: 08/31/2016
• Device Model Number: 5180
• Device Catalogue Number: 5180
• Device Lot Number: S000001462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 02/22/2020; 02/13/2021
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/22/2020; 03/05/2021
• 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
• Patient Weight: 70