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

Model Number 53401

Device Problem Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Device failed incoming testing due to a battery assembly board issue.During final testing the "reverse voltage measured current" failed.There was no text in the display.The device and its boards inside were checked, the firmware was updated and the device passed its final testing with no visual or electrical anomalies noted.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator was returned in accordance with instructions for a field corrective action 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.Benchtop analysis: assembled into a golden unit.Ran on the automated test console.Passed all tests.Reverse voltage current drain measured 1.3 ua.The acceptable range is 0-10 ua.Powered on with no issues.No logs available for review.Conclusion: no defect found if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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: 7971518
• MDR Text Key: 123941933
• Report Number: 3004593495-2018-00995
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 10/05/2018
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 01/29/2019; 01/23/2019
• Supplement Dates FDA Received: 01/29/2019; 02/18/2019
• 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
• Removal/Correction Number: Z-2317-2018
• Patient Sequence Number: 1