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

Model Number DM3500

Device Problems Premature Discharge of Battery (1057); Under-Sensing (1661); Application Program Version or Upgrade Problem (2881); Data Problem (3196)

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

Event Date 05/24/2019

Event Type  Injury  

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 presented in clinic for routine follow up.During upgrade of an implantable cardiac monitor it was noted that the battery level was less than half.Since the battery level was low, possible premature battery depletion was suspected.The implantable cardiac monitor was unable to be upgraded due to low battery level.Hence, programming changes were performed to reduce the number of false positive episodes due to undersensing.However, programming was unsuccessful.An abbott representative was contacted, and it was noted that the device was in a slow bluetooth communication mode and might take some time.Shutting down the programmer and reinterrogating the device was suggested.The patient did not want to wait and left the clinic.The patient was seen in clinic on (b)(6) 2019 and device replacement was discussed.The patient was scheduled for an explant procedure.No intervention has been performed yet and the device remains implanted.The patient was in stable condition.

Manufacturer Narrative

The field event of undersensing and premature depletion was not confirmed.The device was received in normal working condition.Sensitivity test was performed under nominal settings and the implantable cardiac monitor was able to sense within the product specification.Additionally, electrical and mechanical tests were performed and was found to be normal.Upon review of transmission it was indicated that the device transmitted daily during the implant period with maximum telemetry usage which resulted in battery depletion to end of life (eol) level.Visual inspection of header feed through pins was performed and indicated that there was no contamination.Longevity assessment was performed, and the device exceeded the projected longevity based on field settings and battery depletion was considered normal based on the device usage.

Manufacturer Narrative

Further information was requested but not received.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

New information received states that the implantable cardiac monitor was explanted and replaced.

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8683381
• MDR Text Key: 147477323
• Report Number: 2938836-2019-04595
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000055740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 09/19/2019
• Supplement Dates FDA Received: 07/16/2019; 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR