MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONFIRM; RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)

Model Number	DM2100
Medical Device Problem Codes	Difficult to Interrogate (1331); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
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
During a follow-up in clinic, the device was interrogated and the connection was lost.Another attempt to interrogate the device was made and the device was noted to be in backup mode.No intervention was performed and the patient was stable with no consequences.
Event or Problem Description
Additional information received indicated that the device was explanted and replaced due to normal battery depletion.The patient was stable following the procedure.
Additional Manufacturer Narrative
The reported event of backup mode was confirmed.The cause of the backup operation is due to normal battery depletion.Longevity calculations showed the battery was expected to be past end of life (eol) when the field event occurred, and normal current draw was found in the device electronics.

• Brand Name: CONFIRM
• Common Device Name: RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8060726
• Report Number: 2017865-2018-16863
• Device Sequence Number: 2879925
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2019

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: 02/29/2016
• Device Model Number: DM2100
• Device Catalogue Number: DM2100
• Device Lot Number: S000001841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 01/12/2019; 04/16/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/24/2019; 04/22/2019
• 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: Hospitalization; Required Intervention