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

Model Number 5392

Device Problems Computer Operating System Problem (2898); Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2014

Event Type  malfunction  

Manufacturer Narrative

Product event summary: analysis confirmed the reported event, the device powered up with an error and would not do a full test, the main printed circuit board (pcb) was out of electrical specification.It was also noted that the negative battery wire in the lower case was pinched, the display wires were pinched, the encoder flex was damaged and nuts were torqued incorrectly, and there was a metal flake stuck under the polyimide film.

Manufacturer Narrative

Further analysis was performed on the main pcb.Visual inspection revealed no anomalies.Bench analysis revealed a corrupted eeprom.Conclusion: corrupt eeprom, however the cause was unknown.

Event Description

It was reported that the external pulse generator powered up to an error.The generator was powered off and on but the error did not clear.The battery was removed for 4 minutes and then reinserted but the error recurred at power-up.The generator was returned for service.There was no patient involvement.

Manufacturer Narrative

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

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: 4313542
• MDR Text Key: 12966343
• Report Number: 3004593495-2014-00053
• 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,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• 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: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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