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

Model Number DM3500

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896); Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 01/24/2020

Event Type  malfunction  

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 Description

It was reported that the patient passed away on (b)(6) 2020.It was noted that pause episodes were reported to have been sent (b)(6) 2020 from the implantable cardiac monitor (icm).The last transmission and clear date was (b)(6) 2020 but no transmission was received by the clinician and information from electrocardiagrams (egms) were unavailable as they had been cleared.It appeared the device was cleared without a successful transmission and egms were not recoverable.There were no previous concerns relating to pause episodes prior to the event.A mock test of symptom episodes was simulated on (b)(6) 2020 by the clinician after the device was obtained post mortem and the transmission was successful.The clinician understood the implantable cardiac monitor could not have caused the patient death as this was just a monitoring device but wanted to know the cause of death and was unable to do so due to the missing egms.No other patient history was provided apart from old age.

Manufacturer Narrative

The complaint of a transmission problem was not confirmed.Analysis performed indicated that it exhibited normal device characteristics.Visual inspection did not find any foreign material on the header feed through pin that could contribute to the complaint.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9742005
• MDR Text Key: 180548512
• Report Number: 2017865-2020-02433
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2020
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000064818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 06/15/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 101 YR