MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number	DM2100
Medical Device Problem Codes	Inappropriate or Unexpected Reset (2959); Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
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
It was reported that the patient presented for the explant of an implantable cardiac monitor for normal battery depletion.Following the procedure, it was noted that the device was in backup vvi, and the data could not be read.The patient did not experience any consequences.
Additional Manufacturer Narrative
The reported event of no communication was confirmed.The device could not communicate due to low battery voltage.Based on default parameter settings, the device performed to the expected longevity.No high current drain sources were found throughout bench and stress testing.The device was found to be normal.

• Brand Name: CONFIRM
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8906760
• Report Number: 2017865-2019-12535
• Device Sequence Number: 11445853
• Product Code: MXC
• UDI-Device Identifier: 05414734502597
• UDI-Public: 05414734502597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/06/2020

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: 07/31/2016
• Device Model Number: DM2100
• Device Catalogue Number: DM2100
• Device Lot Number: S000009567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1