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

Model Number 2290

Device Problems Failure to Capture (1081); Computer Software Problem (1112); Inadequate User Interface (2958)

Patient Problem Syncope (1610)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during an implant procedure while the patient was being paced with the analyzer the patient became pacing-dependent and the analyzer generated a message "either restart or end session." a temporary pulse generator was used.Follow-up is being conducted to obtain serial number and disposition information on the analyzer.No patient complications have been reported as a result of this event.It was further reported via follow-up that while pace mapping for lead placement the analyzer changed its rate without any command and began pacing at 30 beats-per-minute(bpm) from 130 and generated the "restart or end session" message.The rate was reprogrammed to 130 bpm and a competitor's external pulse generator (epg) was also employed to use as back-up.The analyzer again dropped its rate to 30 bpm and the generated "restart" message recurred and in addition the analyzer failed to capture and the patient went asystolic.Pacing was begun with the epg and simultaneously the hospital electrophysiology technician came on pacing through the mapping system.Both were slaved into the his lead block for signals but since the mapping system could only pace and not test the potential lead it was pulled and only kept as back-up and the case proceeded.The patient sustained a few pauses during the event, with the longest measured at 8 - 9 seconds.Neither the analyzer nor the lead have been received into service.

• Brand Name: CARELINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC INC.; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC INC.; 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: 7461769
• MDR Text Key: 106573443
• Report Number: 2182208-2018-00747
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2290
• Device Catalogue Number: 2290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2018
• 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
• Patient Outcome(s): Life Threatening; Required Intervention