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

Model Number GC3

Device Problem Data Problem (3196)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that when session data from the programmer was imported to the patient management database application as an in-office encounter, the number of atrial high rate episodes did not match.The programmer printout was displaying the number of episodes as (b)(6), but the application listed the number of episodes as (b)(6).The current status of the programmer and application are unknown.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported the customer mis-read the report; values were the same.It was communicated to the customer there were two different values, atrial high rate episodes and auto mode switch episodes.The programmer and application remain in use.

• 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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6466824
• MDR Text Key: 72241407
• Report Number: 2182208-2017-00426
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GC3
• Device Catalogue Number: GC3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 06/19/2017; 06/19/2017
• Supplement Dates FDA Received: 08/09/2017; 09/06/2017
• 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
• Treatment: 2090 PROGRAMMER
• Patient Age: 79 YR