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

Model Number 5392

Device Problems Computer Software Problem (1112); Pacing Intermittently (1443)

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

Event Date 07/17/2014

Event Type  malfunction  

Event Description

It was reported and error occurred and pacing intermittent off.The device was returned for repair.No patient complications were reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Manufacturer Narrative

Product event summary: analysis confirmed the reported event, the main printed circuit board (pcb) was out of electrical specification.The display wires were not routed properly, they were routed around a display frame screw and were tight once, plugged into the main pcb connector.The keypad and one knob were contaminated, and the encoders were not torqued properly, the torque was out of specification on the low side.

Manufacturer Narrative

Further analysis was performed on the main printed circuit board (pcb).Visual inspection revealed no anomalies.Bench analysis revealed no error during power up.Conclusion: the reported event was confirmed by log analysis.An error triggered the out of service error seen by the customer, however analysis was unable to reproduce the error.

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): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4311868
• MDR Text Key: 5255981
• Report Number: 3004593495-2014-00049
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K132924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2014

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: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/21/2015
• Supplement Dates FDA Received: 02/10/2015; 04/10/2015; 09/15/2017
• 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