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

Model Number 5392

Device Problem Under-Sensing (1661)

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

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that while an external pulse generator (epg) was pacing the health professional was slowly decreasing the pacing rate the epg turned off and asystole resulted.Cardiopulmonary resuscitation for approximately one minute was required.The epg was turned back on and pacing resumed, however some time later the epg turned off again and again asystole resulted.The epg was changed out at this time, replaced by a different model of dual-chamber epg and the patient was transported to the electrophysiology lab for implant of a permanent pacemaker.It was noted that once there external transthoracic pacing pads began pacing the patient for unknown reasons.The epg that reportedly turned off is expected to be returned for analysis.No further patient complications have been reported as a result of this event.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9185055
• MDR Text Key: 162375273
• Report Number: 3004593495-2019-01068
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169230859
• UDI-Public: 00643169230859
• 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: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• 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?: No
• Date Manufacturer Received: 10/03/2019
• Date Device Manufactured: 03/26/2014
• 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): Required Intervention