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

Model Number 53401

Device Problems Under-Sensing (1661); Output Problem (3005)

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

Event Type  Injury  

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) was not pacing and sensing consistently.After placement of the pacing wire and prepping to set the pacer, there was very little sensing or capture getting up to about 15a and then after manipulating the connections the capture happens and the patient¿s chest jumped.Occasionally, the capture holds and other times it does not and has to be adjusted again.Multiple cables and pacing wires were used for troubleshooting and the issues persisted.It was recommended that the epg be returned for service, but its current status is unknown.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Analysis was unable to confirm the customer comments that the epg was not pacing and sensing consistently.All found defective parts were replaced and all other identified issues were resolved.The device then passed all functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the epg was returned for service.

• Brand Name: TEMPORARY EXTERNAL 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: 9353886
• MDR Text Key: 167351342
• Report Number: 3004593495-2019-01219
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53401
• Device Catalogue Number: 53401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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