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

Model Number 5392

Device Problem Sensing Intermittently (1558)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product event summary: analysis was unable to confirm the customer comment of intermittent signal, the device passed all on its visual incoming inspection and no anomalies were found.It was recalibrated and functionally tested and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator was getting an intermittent signal.The generator was returned for service.There was no patient involvement.

• 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: 7091313
• MDR Text Key: 94283718
• Report Number: 3004593495-2017-00687
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169508767
• UDI-Public: 00643169508767
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• 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: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1