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

Model Number 2090AA

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis was unable to confirm the programmer was crashing.However, a sensor error was found in the logs and the micro processor unit (mpu) was replaced as a preventative.The hard drive was reconfigured, and the software was reloaded and updated.Analysis also noted that the replacement handles were cracked.The handles were replaced.The device passed final functional and system tests.No other anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer was crashing after several minutes.The programmer was returned for service.No patient complications have been reported as a result of this event.

• Brand Name: CARELINK
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7614850
• MDR Text Key: 111678675
• Report Number: 2182208-2018-01148
• 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: Other
• Type of Report: Initial
• Report Date: 06/19/2018

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: 05/31/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2003
• 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