MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5318

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) could not be used normally after being turned on.The epg was returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis confirmed the customer comment.The sensing was lost at one millivolt test and the calibration was invalid.Cover ring attachment p was broken.Printed circuit board (pcb) and cover ring attachment were replaced.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9499936
• MDR Text Key: 175650984
• Report Number: 3004593495-2019-01336
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5318
• Device Catalogue Number: 5318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2010
• 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