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

Model Number 2090AM

Device Problems Device Emits Odor (1425); Power Problem (3010)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer's analysis confirmed the customer comment that the programmer turned off suddenly and failed to switch on again and an odor was coming from the power supply.It was indicated that the power supply was out of specification electrically.It was also indicated that the power cord bay was broken.These parts were replaced and the programmer passed final functional and system tests.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 the programmer turned off suddenly and failed to be switched on again.It was also reported that a burning smell was coming from the cooling system.The programmer was returned for service.No patient complications have been reported as a result of this event.

• 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, 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: 6470465
• MDR Text Key: 72177749
• Report Number: 2182208-2017-00652
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/03/2017

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: Other
• Device Model Number: 2090AM
• Device Catalogue Number: 2090AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2002
• 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