MAUDE Adverse Event Report: MEDTRONIC, INC. PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER

Model Number	R2290
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that the programmer displayed an error message when attempting to connect to the analyzer.It was noted that the programmer communicated as required when a known good analyzer was used.The analyzer was replaced with an alternative analyzer.The replacement analyzer 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 when attempting to connect to the analyzer, the programmer displayed an error message.The analyzer was returned to service as an associate product and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• Brand Name: PACING SYSTEM ANALYZER
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 12737213
• Report Number: 2182208-2021-04305
• Device Sequence Number: 4557875
• Product Code: KRG
• UDI-Device Identifier: 00721902710322
• UDI-Public: 00721902710322
• 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): 11/02/2021

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
• Operator of Device: Other
• Device Model Number: R2290
• Device Catalogue Number: R2290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2067 RADIOFREQUENCY HEAD, 2090 PROGRAMMER