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

Model Number 2292

Device Problems Signal Artifact/Noise (1036); No Device Output (1435); Material Integrity Problem (2978)

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

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

Non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was noise present on both the atrial and ventricular electrograms while using the analyzer.It was noted that recently it had been able to pace using cables in conjunction with the analyzer but only on the ventricular channel, the atrial channel had all noise.New cables were tried and the issue persisted.It was also reported that when disposable cables were used when attempting his bundle pacing there was also noise present, and that for this type of case they were slaving off of the hospital's electrophysiological (ep) system.The hospital replaced the power strip that the programmer was being plugged into as a troubleshooting measure however it did not resolve the issue.A biomedical engineer investigated and was not able to identify a possible source within the rooms.It was also noted that this is a recent problem, ongoing for only about a month.The programmer and the analyzer have been returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: ANALYZER CABLE
• 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: 7878593
• MDR Text Key: 120335880
• Report Number: 2182208-2018-01699
• 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,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2292
• Device Catalogue Number: 2292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2018
• 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
• Treatment: 2090 PROGRAMMER, 2067 RADIO FREQUENCY HEAD, 2290ANALYZR
• Patient Outcome(s): Required Intervention