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

Model Number DM3500

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2018

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 device displayed low battery longevity estimation than expected.It was noted that the device had latest firmware which would resolve the issue.Patient was monitored.Device also reached pre-eri trigger few days after the implant.Analysis of battery voltage trend showed that the device exhibited a temporary voltage drop prior to implant that was likely associated with exposure to cold weather.After implant, the voltage recovered to expected values.The low battery status on the device was a diagnostic anomaly, and the clinic could expect the full 2 year longevity with normal usage.No patient symptoms were reported.Patient will be monitored.

Manufacturer Narrative

The device had triggered pre-eri flag on (b)(6) 2018.This occurred prior to the device implant.On (b)(6) 2018, the battery voltage was completely back to normal.

Event Description

New information received notes that patient will be called in clinic to reset the false pre-eri flag.The battery voltage is at normal levels.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7449820
• MDR Text Key: 106143051
• Report Number: 2938836-2018-03657
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000051779
• Other Device ID Number: 05415067027320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2017865/04/16/18/003-C
• Patient Sequence Number: 1
• Patient Age: 76 YR