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

Model Number 5392

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of the device was unable to confirm the customer comment of a pulse timing issue.The device passed all automated and bench testing with no anomalies found.The device passed all final functional tests.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 an issue ¿¿timing the pulse¿¿.The device has been returned for service.It was reported that the epg may have caused an issue with a patient.

• 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: 10331118
• MDR Text Key: 200588949
• Report Number: 3004593495-2020-00786
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150246
• 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
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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
• Patient Outcome(s): Required Intervention