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 Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.

Event Description

It was reported that the external pulse generator (epg) was in use with a patient when it stopped functioning and displayed an error.The epg was replaced and is expected to be returned.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: analysis confirmed the reported issue; the device powers up to an error and the main printed circuit board (pcb) is electrically out of specification.Additional errors were found in the logs.It was also found that one case screw was contaminated.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) was in use with a patient when it stopped functioning and displayed an error.The epg was replaced and has been returned for repair.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection revealed no anomalies.Benchtop analysis found that the unit powered on to an error.After the eeprom (electrically erasable programmable read-only memory) was replaced, all tests passed on the automated test console.Errors were also displayed in the logs.Conclusion: the reported event was confirmed, the failure was caused by a corrupt eeprom.One of the errors was confirmed in the log but could not be confirmed on the bench.If information is provided in the future, a supplemental report will be issued.

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): 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: 6320510
• MDR Text Key: 67080705
• Report Number: 3004593495-2017-00087
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• 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: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 60