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

Model Number 5392

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It was reported that the customer was in-servicing a new device and when the device was turned on it displayed an error.It is expected that the device will be 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.(b)(4).

Manufacturer Narrative

(b)(4).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 battery drawer wires were pinched, the display wire insulation was pinched but the wire insulation was not compromised, the encoder nuts were not torqued to specifications, one case screw was contaminated.

Event Description

It was reported that the customer was in-servicing a new epg (external pulse generator), and when the epg was turned on, it displayed an error message.The epg was returned for repair.There was no patient involvement.

Manufacturer Narrative

Further analysis was performed on the main board.Visual inspection did not reveal any anomalies.Bench analysis did not find any anomalies.All circuitry operated normally.The log was also analyzed; the device had many normal power ups, during a scheduled battery/super cap measurement the super cap measured high which caused an error.The next power up cycle caused the displayed error to occur.Conclusion: it was confirmed by log analysis that a "super cap high" error triggered an out of service error, however analysis was not able to reproduce the error.

• 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: 4498968
• MDR Text Key: 5345002
• Report Number: 3004593495-2015-00023
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

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: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• 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
• Removal/Correction Number: Z-1356-2015
• Patient Sequence Number: 1