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

Model Number 5392

Device Problems Intermittent Capture (1080); Sensing Intermittently (1558)

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

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the external pulse generator (epg) experienced intermittent sensing and capture at maximum sensitivity and maximum outputs while in use with a patient.The caller was advised to have the epg checked by the biomedical engineering department to ensure proper function of sensing and pacing, and to return for evaluation if not in appropriate ranges.The status of the epg is unknown at this time.No patient complications have been reported as a result of this event.Describe event/steps taken: caller discussed the scenarios in that at times the epg senses and captures and then other times it is intermittent in its sensing and its capture at max sensitivity and max outputs.Caller noted she was testing a patient and had r wave sensing at 2 mv, pacing at 3, then pacing back at 2, at 1 and at.8mv and then finally got sensing back at 2 mv at some point.We discussed having the epgs checked by the biomed dept to ensure their proper function of sensing and pacing.We discussed the possibility that the lead may have moved or may be moving or not in a great location.Device should be sensing.

• 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): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8345188
• MDR Text Key: 136910010
• Report Number: 3004593495-2019-00145
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 01/25/2019
• 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