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

Model Number 5392

Device Problems Computer Software Problem (1112); Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported that the external pulse generator powered up to an error and that it was unable to be cleared.It was further noted that the batteries being used did not seem "sloppy" in the drawer.The generator was returned for a warranty service.There was no patient involvement.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product event summary: analysis confirmed the reported event, the main printed circuit board (pcb) was out of electrical specification.It was also noted that the lower case was broken, the display wires were pinched, the encoder nuts were not torqued to specification and five case screws were contaminated.(b)(4).

Manufacturer Narrative

Further analysis was performed on the main board and lower case.Visual inspection revealed no anomalies on the main board.The lower left hand screw boss was broken on the case.Bench analysis revealed that all testing passed.The error log indicated that the device powered up normally 10 times, but on the 11th power up cycle an error for voltage being too low occurred.The displayed error then triggered on the next power up.Conclusion: customer complaint was confirmed.

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: 4497535
• MDR Text Key: 5350889
• Report Number: 3004593495-2015-00005
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• 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: 12/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1356-2015
• Patient Sequence Number: 1