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

Model Number 5392

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: manufacturer's analysis indicated that the external pulse generator (epg) main printed circuit board (pcb) was out of specification.It was also indicated that multiple external components were damaged.The epg was repaired and returned to use.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator (epg) was returned for testing and calibration and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Product analysis: further analysis indicated that the external pulse generator (epg) main printed circuit board (pcb) was not out of specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• 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: 9477371
• MDR Text Key: 175648772
• Report Number: 3004593495-2019-01302
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169725126
• UDI-Public: 00643169725126
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• 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: 12/03/2019
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• 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