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

Model Number 2090AA

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that there was an odor coming from the programmer when it was turned on.The power supply was replaced.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was an odor coming from the programmer every time it was turned on.The programmer was returned for analysis.There was no patient involvement.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.

• Brand Name: MEDTRONIC CARELINK PROGRAMMER WITH ANALYZER
• 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: 9956587
• MDR Text Key: 187551794
• Report Number: 2182208-2020-00709
• Device Sequence Number: 1
• Product Code: KRG
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2090AA
• Device Catalogue Number: 2090AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2002
• 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
• Treatment: 2067 RADIO FREQUENCY HEAD