MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK; PROGRAMMER, PACEMAKER

Model Number 2090

Device Problems Device Emits Odor (1425); Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2013

Event Type  malfunction  

Event Description

It was reported that during an attempted software upgrade to the programmer, it sounded as though the cooling fan kicked on, and then it started to smell like an electrical fire.The programmer was returned for service.There was no patient involvement.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis confirmed the customer comment "started to smell like an electrical fire." the power supply was hot and found to be out of electrical specification.The system fan was also replaced because it was noisy, and errors were noted in the programmer history log; software was reloaded.(b)(4).

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 4310087
• MDR Text Key: 5271472
• Report Number: 2182208-2014-03160
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2013

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: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2013
• Initial Date FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2002
• 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