MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number	DM2100
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Patient Involvement (2645)
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
An explanted device was interrogated.Upon interrogation, the incorrect device model was noted on the printout.No intervention was performed as there was no patient involved.
Additional Manufacturer Narrative
Upon receipt, the device was unable to be interrogated with a programmer.The reported event of diagnostics issue was unconfirmed.The event description was reviewed and showed behavior consistent with a low battery voltage.In-lab testing and analysis was performed.The device battery was measured with a digital multimeter at 0.53v and no source of high current drain was identified.A longevity estimate was performed and showed normal battery depletion.
Event or Problem Description
Additional information received indicated that the device was implanted in 2014 or 2015.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8327798
• Report Number: 2017865-2019-02073
• Device Sequence Number: 139746
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K101968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 03/30/2015
• Device Model Number: DM2100
• Device Catalogue Number: DM2100
• Device Lot Number: 4525552
• 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: 01/28/2019
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1