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

Model Number 2090

Device Problems Device Emits Odor (1425); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis confirmed the customer comment that a burnt odor was coming from the power supply and the power supply was therefore replaced.It was verified that there were no burnt caps or odor coming from the micro processing unit.The release lever was missing from the printer drawer and the printer drawer was replaced, the media bay door was missing and it was replaced.The circuit boards and mechanical parts were inspected, the hard drive reconfigured, the software reloaded and updated and the device then passed all final functional and systems tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was dropped and that it smells as though wires are burning, and it shorts out.The programmer was returned for service.There was no patient involvement.

• 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: 7416895
• MDR Text Key: 105181977
• Report Number: 2182208-2018-00526
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994175397
• UDI-Public: 00613994175397
• 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: 04/10/2018

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: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2003
• 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