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

Model Number 2090

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the complaint was confirmed.The power supply was found to be defective, and the fan was found to be noisy.The power cord bay was found to be broken.All found defective parts were replaced and all other identified issues were resolved.The hard drive was reconfigured, the software was reloaded and updated, and the device 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 emitted a burning smell, during use.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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8379916
• MDR Text Key: 137468541
• Report Number: 2182208-2019-00392
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2019

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: 12/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2002
• 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