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

Model Number 229047

Device Problems Electrical /Electronic Property Problem (1198); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis :analysis was able to confirm the customer comment that there was noise on the atrium and ventricle channel of the analyzer, it was identified that the patient connection has disturbed pins.The device will be repaired and a replacement device has been provided.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was noise on the atrium and ventricle channel of the analyzer.The analyzer was returned for analysis.No patient complications have been reported as a result of this event.It was further reported that the programmer subsequently tested out of specification during manufacturer's analysis.

• Brand Name: PACING SYSTEM 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: 9909539
• MDR Text Key: 187206910
• Report Number: 2182208-2020-00640
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902256011
• UDI-Public: 00721902256011
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 229047
• Device Catalogue Number: 229047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2003
• 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