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

Model Number 5392

Device Problems Computer Software Problem (1112); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2014

Event Type  Injury  

Event Description

It was reported that while pacing a patient the external pulse generator generated an error and stopped pacing.The generator was returned for service.No patient complications have been reported as a result of this event.

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

Product event summary: analysis confirmed the reported event regarding the errors, the main printed circuit board (pcb) was out of electrical specification.It was also noted that the display wires were pinched and routed improperly, one display shoulder screw was damaged, and the encoder nuts were not torqued properly to specification.

Manufacturer Narrative

Further analysis was performed on the main board.Visual inspection revealed no anomalies.Bench analysis found that the device powered up normally with the main board.Additional analysis found that all tests passed on the test console.Conclusion: it was confirmed by error log analysis that an error occurred which triggered the displayed error, however, it was not possible to reproduce the error.It could not be determined if the device shutdown while in use.

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: 4314556
• MDR Text Key: 5241015
• Report Number: 3004593495-2014-00070
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2014

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?: 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: 09/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• 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
• Patient Outcome(s): Required Intervention