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

Model Number 5392

Device Problems Device Displays Incorrect Message (2591); Failure to Shut Off (2939)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that right out of the box the external pulse generator had an error message "button press detected" at power up.The batteries were removed and the device powered down, however upon power-up the message reappeared.It was attempted to just turn the device off but it was not possible.The generator was returned for service.There was no patient involvement.

Manufacturer Narrative

Product event summary: analysis confirmed the reported event, the keyboard was out of electrical specification.It was also noted that the battery wire insulation was pinched but the wire insulation was not compromised, there were sixteen stuck buttons detected in the device log, and one stuck button was recovered.The keypad was replaced.

Manufacturer Narrative

Further analysis was performed on the keypad.Visual inspection revealed depressions in the keypad flex circuit on both traces from the doo button.Bench analysis found that a microscope image did not confirm a breach in the flextape layer.A hipot test was performed, a trace broke down at 2300 vdc, and the lower trace broke down at 800 vdc indicating a very small break in the insulating layer.The log was also reviewed, it showed the keypad doo key was the reason for the unit powering up, also had a stuck key reported.Conclusion: the doo button traces on the keypad flex were forced down on top of a main board component causing a short between the two traces.The reason for the flex being forced down was the battery wires were pinched during assembly of the device.

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: 5279959
• MDR Text Key: 33530536
• Report Number: 3004593495-2015-00377
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2015

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: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/09/2016
• Supplement Dates FDA Received: 02/09/2016; 08/09/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• 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