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

Model Number 5392

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

It was reported that the seal on the external pulse generator (epg) was not in place.It is expected that the epg 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

Product event summary: analysis confirmed the customer comment that the seal was not in place, the main seal was pinched and exposed outside of the case.The main seal was inspected and no anomalies were observed but it was to be sent to failure analysis as a preventive.It was additionally noted that the output connector assembly black wire was exposed at the crimp and that during removal for repair the black came loose from the crimp, that the display wire insulation was pinched though the wire insulation was not compromised and that the encoder nuts were not torqued to specification.All found defective parts were replaced and all other identified issues were resolved.

Event Description

It was further reported that the generator was returned for service, and analyzed.

Manufacturer Narrative

Further analysis was performed on the patient cable assembly.Visual inspection revealed that the black wire was pulled from the crimp.Conclusion: the wire was pulled from the crimp at service, two of the seven wires appear to not have been included in the crimp which would cause less pressure in the crimp.

• 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: 4497504
• MDR Text Key: 19802988
• Report Number: 3004593495-2015-00007
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132924
• 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
• Report Date: 03/17/2015

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?: No
• Date Manufacturer Received: 08/12/2015
• 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