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

Model Number 5392

Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer¿s analysis confirmed the customer comment via the device log that the device presented with error codes and stopped working; the main printed circuit board (pcb) assembly of the device tested out-of-specification in an electrical manner.It was also noted that three case screws were contaminated, and both display and lower case wires were pinched without compromise to the insulation.All found defective parts were replaced and all other identified issues were resolved.

Event Description

It was reported that the external pulse generator stopped working and presented with an error code.After the external pulse generator was re-booted, it then presented with a different error code.The external pulse generator has been returned for repair, and a loaner was requested.There was no patient involvement.

Manufacturer Narrative

Failure analysis was performed on the main printed circuit board assembly.Visual inspection revealed no anomalies.Bench analysis found that the device powered up normally.The device was run on the automated test console, all tests passed.The device was placed in an oven at 158f overnight, no error then put in the freezer for an hour, no error.The device was then put directly back in the oven, when checked an hour later an error was present.Additional analysis: the error log was reviewed, the log showed multiple errors.The errors were for a timeout waiting for event latch write by die stack.Conclusion: confirmed the reported event, suspected solder issue with the die stack.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6008793
• MDR Text Key: 56825295
• Report Number: 3004593495-2016-00431
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

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: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2015
• 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