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

Model Number 2090

Device Problems Computer Software Problem (1112); Device Emits Odor (1425)

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

Event Date 10/02/2014

Event Type  malfunction  

Event Description

It was reported that when the physician was performing a device follow up, the programmer displayed a black screen with an error code.The physician then smelled smoke from the back of the programmer.Immediately the programmer was turned off and the manufacturer was called.The next day the programmer was checked and everything was working fine.A device was interrogated, no smoke smell from the programmer.After contacting the manufacturer it was recommended that the programmer be replaced and sent to the manufacturer for analysis and servicing.No patient complications have been reported as a result of this event.

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 when the physician was performing a device follow up, the programmer displayed a black screen with an error code.The physician then smelled smoke from the back of the programmer.Immediately the programmer was turned off and the manufacturer was called.The next day the programmer was checked and everything was working fine.A device was interrogated, no smoke smell from the programmer.After contacting the manufacturer it was recommended that the programmer be replaced and sent to the manufacturer for analysis and servicing.The programmer was later returned to the manufacturer.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: analysis could not confirm the reported event.The device was disassembled and the link electronic module (lem) circuit board, main processing unit and power supply were inspected.No tracks of burning components were found.

• 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: 4314191
• MDR Text Key: 15103481
• Report Number: 2182208-2014-03723
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

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: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2009
• 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