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

Model Number 5392

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: manufacturer's analysis indicated that the external pulse generator (epg) main printed circuit board (pcb) was defective.The epg was repaired and returned to use.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator (epg) was returned for testing and calibration and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection: no anomalies - main board found to be clean and in good condition.Benchtop analysis: assembled into a golden unit.Ran on automated test console.Failed atrial blanking and atrial sensitivity at all tested levels (1mv, 2mv, 5mv, and 10mv).Benchtop test using sigma pace 1000 analyzer confirmed atrial sensitivity failure at all levels tested.Ventricular sensitivity found to be within spec.Engineering evaluation and troubleshooting found problem related to a capacitor.Replaced capacitor with a known good capacitor fix the problem.Benchtop test using sigma pace 1000 analyzer confirmed atrial sensitivity pass all tests.Re-run the unit through automated test with full test ¿ all passed.Out of circuit measurement of original capacitor removed from the board found the capacitance within 10% tolerance spec.This confirmed no defect of the original capacitor.Replaced the original capacitor back on the main board.Re-run the unit through benchtop test and automated test ¿ all passed.Based on this analysis data, the root cause is more likely related to capacitor terminal contamination on the board.Confirmed customer complaint.Device failed atrial blanking and atrial sensitivity.Failure caused by capacitor terminal contamination.If information is provided in the future, a supplemental report will be issued.

• 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: 8789678
• MDR Text Key: 151001687
• Report Number: 3004593495-2019-00690
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 11/06/2019
• 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