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

Model Number 2090W

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

At analysis it was noted that the programmer no longer powered on and the power supply was therefore replaced.Re configured hard drive, reloaded and updated software.The programmer passed all console and systems tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was a popping sound and the programmer smelled as though something was burning.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: 7511515
• MDR Text Key: 108237902
• Report Number: 2182208-2018-00905
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00613994127631
• UDI-Public: 00613994127631
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/14/2018

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: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2006
• 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