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

Model Number DM3500

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); Appropriate Term/Code Not Available (3191); Wireless Communication Problem (3283)

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

Event Date 06/03/2019

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 implantable cardiac monitor exhibited no telemetry upon interrogation.Location was changed and two different programmers were unable to interrogate the device.Patient will be interrogated again during next clinic visit.Patient was stable.

Manufacturer Narrative

(b)(4).

Event Description

New information received stated that the patient presented in clinic where the implantable cardiac monitor was attempted to be interrogated multiple times.A magnet was placed over the device to reset bluetooth.Attempts were unsuccessful.Possible explant and re-implant were discussed.

Event Description

New information received stated that the implantable cardiac monitor was explanted on (b)(6) 2019.Patient was stable post procedure.

Manufacturer Narrative

Final analysis found that the device could not establish bluetooth communication due to premature battery depletion.Foreign material shorted the positive battery terminal to ground.A manufacturing anomaly may have occurred that resulted in the reported issue.

Event Description

New information received noted that the implantable cardiac monitor was unable to be interrogated due to premature battery depletion.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8694044
• MDR Text Key: 147858386
• Report Number: 2017865-2019-09551
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/23/2019

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: 10/25/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: S000060209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/14/2019; 07/11/2019; 09/06/2019
• Supplement Dates FDA Received: 07/01/2019; 07/15/2019; 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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: 77 YR