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 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the caller stated that when the device was interrogated the device was elective replacement indicator (eri) with settings of vvi 65.After uploading the programmer data to the patient management database application, the atrial ohms were displayed as 67 ohms.The atrial lead was off due to the device being at eri and possibly due to an erroneous number during the data transfer.The caller was advised to test the lead during a generator change to ensure the atrial lead was functioning normally.The 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, 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: 8026346
• MDR Text Key: 125772633
• Report Number: 2182208-2018-01986
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2018

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: GCIII
• Device Catalogue Number: GCIII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 10/31/2018
• 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
• Patient Age: 56 YR