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

Model Number 2090W

Device Problems Device Emits Odor (1425); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2009

Event Type  malfunction  

Event Description

It was reported that a spark was seen from the power socket in the programmer when the power was plugged in and switched on.A burning smell followed.The programmer was returned for repair.No patient involvement or complications have been reported as a result of this event.

Manufacturer Narrative

This event was assessed and is being reported as a part of a retrospective review of events, which was in response to mdr criteria revisions and on-going process improvements.The 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.Product event summary: analysis could not confirm the reported event of "spark" or "burning smell." however, the device would not power up.The power supply was out of electrical specification and was replaced.(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: 4609756
• MDR Text Key: 18918624
• Report Number: 2182208-2015-00766
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2009

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2009
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2009
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2006
• 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