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

Model Number	2090
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: analysis of the programmer was unable to confirm the customer comment that the session could not be ended.Analysis also noted that the stylus did not align with the cursor, the lower handle cover was cracked and the programmer failed left antenna test at functional testing.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the programmer had to be powered off in order to end session after the interrogation of an implantable device.The programmer was returned for service and subsequently tested out-of-specification during manufacturers analysis.There was no patient involvement.

• Brand Name: CARELINK PROGRAMMER
• Common Device Name: 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: 13997730
• Report Number: 2182208-2022-01029
• Device Sequence Number: 11978304
• Product Code: KRG
• UDI-Device Identifier: 00613994434937
• UDI-Public: 00613994434937
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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
• Operator of Device: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown