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

Model Number 5392

Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2014

Event Type  malfunction  

Manufacturer Narrative

Further analysis was performed on the main pcb.Visual inspection was performed, no anomalies observed.Bench analysis confirmed the error number.Additional analysis indicated that the error displayed during a self-test.The error is a communication error between the microprocessor and the die stack (pacing engine).The board was x-rayed to look for any solder issues, none were observed.The die stack component was then exposed to a solder reflow process, the board still failed.A new die stack was installed on the board and it still failed.The root cause for this failure is unknown at this time.

Event Description

It was reported that an external pulse generator (epg) will not turn on and when it does turn on sometimes, it gives an error message.The epg was returned to the manufacturer for servicing.There was no patient involvement.

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.Product event summary: analysis confirmed the reported event.The unit would not switch on.After reinserting the batteries, the unit starts up with an error, indicating that the main printed circuit board (pcb) was defective.The unit was then cleaned an inspected, and the main pcb was replaced.The unit was then tested and calibrated on an automated test system, then it passed testing.(b)(4).

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 1190 0; 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: 4158586
• MDR Text Key: 12883483
• Report Number: 3004593495-2014-00035
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K132924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2014

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: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2015
• 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