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

Model Number DM3500

Device Problem Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Patient called in.Patient's original implanting physician at (b)(6) is dr.(b)(6).The patient was seen by dr.(b)(6) who initially confirmed the migration.Further information was requested but not received.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's app and implantable cardiac monitor (icm) were not working and had never worked.The patient wanted the device to be explanted.The patient presented for an in clinic visit and it was observed that the icm had migrated to the bottom of her breast close to her nipple.The physician at her current facility advised the patient to go to her original implanting physician to have the device explanted as it would require major surgery and he was unable to complete it.The device was at end of life (eos) and was awaiting explant.

Event Description

New information notes the implantable cardiac monitor was explanted and replaced.The patient was stable.

• 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: 10387564
• MDR Text Key: 202346118
• Report Number: 2017865-2020-10839
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000060645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR