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

Model Number 2090

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

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer had a burning smell when turned on.The programmer was returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis confirmed customer comment of a burning smell coming out of power supply.Replaced power supply with salvage part.All salvage parts have been inspected per applicable requirements.Reconfigured hard drive, reloaded and updated software.Device passed all final functional and systems tests.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK PROGRAMMER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9558464
• MDR Text Key: 173979988
• Report Number: 2182208-2020-00030
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: 12/20/2019
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2008
• 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
• Treatment: 229047 ANALYZER