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

Model Number 229047

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis:analysis was unable to confirm the customer comment that the analyzer would not start up and that it always stopped after successful attempts to start the analyzer.It was noted that the battery was depleted, the device was mechanically intact and the device passed all incoming functional tests.The battery was replaced and the device 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 analyzer would not start up.After a few attempts it successfully starts but always stops again.There was no patient involvement.It was further reported that the analyzer was returned for service.

• 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: 10108361
• MDR Text Key: 193297873
• Report Number: 2182208-2020-01001
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00721902256011
• UDI-Public: 00721902256011
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• 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: 05/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2002
• 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: 2090 PROGRAMMER.