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

Model Number 2090

Device Problem Inadequate User Interface (2958)

Patient Problem No Code Available (3191)

Event Date 02/23/2015

Event Type  Injury  

Event Description

It was reported that during a routine implant procedure the programmer's software analyzer was undersensing atrial activity.The programmer was replaced and the case was successfully completed.The programmer and the analyzer were both returned to service and it was requested that their interaction be checked for accurate performance.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant product: product id 229047 software analyzer (b)(4).

Manufacturer Narrative

Product event summary: analysis was unable to confirm the customer comment of undersensing of atrial activity.The hard drive was r econfigured and the software reloaded and updated.The device passed all final functional and systems tests.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4676938
• MDR Text Key: 5636228
• Report Number: 2182208-2015-01371
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2015

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: 02/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided; 03/26/2015
• Supplement Dates FDA Received: 06/10/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 2067 RADIOFREQUENCY PROGRAMMER HEAD