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

Model Number 2090

Device Problems Operating System Becomes Nonfunctional (2996); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was unable to confirm the reported "blackout".However, analysis was able to confirm that the programmer was making a noise.The micro processor unit (mpu) was replaced.Analysis also noted that the programmer had a long boot time.The hard drive was reconfigured, and the software was reloaded and updated.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 experienced a "blackout" and made a strange noise.The programmer was returned for service.There was no patient involvement.

• Brand Name: CARELINK PROGRAMMER
• 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: 8663313
• MDR Text Key: 146935863
• Report Number: 2182208-2019-01014
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2019

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: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2003
• 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