MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

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

Event Date 08/14/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).

Event Description

It was reported that there is concern using the newest model external pulse generator (epg) during electrocautery/ablation procedures.The concern was due to a configuration, which was present in the previous model, having been removed from the programming options.This current configuration mode can result in asynchronous dual chamber pacing and in certain modes can prevent t-wave pacing.It was also noted that this model switches from ddd mode to a vvi protection/backup mode, which is an undesirable mode during induced oversensing and also when the patient has an intrinsic normal atrial ventricular (av) conduction.When the emergency mode is pressed, all outputs are maximized and need to be reduced manually or health professionals are not fast enough to switch to this emergency mode.Specific model numbers, dates and patient information were unable to be provided as the health care profession provided this information past the purported incidents; however, in no case was it suggested that the epg malfunctioned or did not perform as designed; rather the concern is that the mode configuration could place the patients at risk during electrocautery/ablation procedures.The status of the epgs is unable to be determined.No further patient complications have been reported as a result of this event.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• 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: 5122398
• MDR Text Key: 27413000
• Report Number: 3004593495-2015-00269
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• 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