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

Model Number 2090AA

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the programmer would not remain powered on and it was noted that this was due to an micro processor unit (mpu) board failure.It was noted that the system fan was noisy.The hard drive was reconfigured and the programmer software was reloaded and updated.All found defective parts were replaced and all other identified issues were resolved.The programmer 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 the programmer would not remain powered on.An alternative power cord was used however this did not resolve the issue.It was also reported that there was a "burnt electrical smell" from the programmer.There was no patient involvement.

• 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: 12666708
• MDR Text Key: 277459419
• Report Number: 2182208-2021-04169
• 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: 10/20/2021

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: 2090AA
• Device Catalogue Number: 2090AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/20/2021
• Date Device Manufactured: 12/16/2002
• 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: R2067 RADIOFREQUENCY HEAD