MAUDE Adverse Event Report: MEDTRONIC, INC. PACEART SYSTEM; ELECTROCARDIOGRAPH

Model Number GCIII

Device Problem Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that the data was sent to the wrong patient record.The caller was walked through how the data could end up at the wrong patient record through reassigning the test or matching to the wrong patient.The caller was advised that the without the auditing feature turned on or seeing the history in the data exchange log viewer (delv) we are unable to determine how the data got to where it is.The caller was advised about the option of auditing to track the movement of the encounters.The patient management database application remains in use.There was no patient involvement.

• Brand Name: PACEART SYSTEM
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5279490
• MDR Text Key: 33554068
• Report Number: 2182208-2015-04131
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K024278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GCIII
• Device Catalogue Number: GCIII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1