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

Model Number DM3500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Twiddlers Syndrome (2114); No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

It was reported that when the patient presented for a follow-up in clinic, the patient had removed their implantable cardiac monitor from the pocket.The patient was stable following and there are no plans to replace the device.

Manufacturer Narrative

Analysis was normal.No anomaly was found.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8857847
• MDR Text Key: 153213234
• Report Number: 2938836-2019-05980
• 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,Followup
• Report Date: 11/19/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000070081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/29/2019; 11/19/2020
• Supplement Dates FDA Received: 09/11/2019; 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other