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

Model Number 53401

Device Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2018

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.The epg was repaired and returned to service.This device was reported as included in the field action noted and returned product investigation found the device performed as described in the field action.If information is provided in the future, a supplemental report will be issued.

Event Description

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

Manufacturer Narrative

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

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection: no anomalies.Benchtop analysis: assembled into a golden unit.Ran on the automated test console.Failed 0.4mv ventricular sensitivity sense.Powered up on the bench and tested sensing using sigma pace 1000 ventricular channel.With the epg at 0.4mv sensing the sigma pace measured sensing at 0.45mv.Ran the sigma pace 1000 0.4mv sensitivity sensing test on a known good unit with the same result of 0.45mv.Executed 0.4mv sensitivity sensing test on both units a second time with the same results.A result of 0.45mv is within the +/- 55% tolerance requirement.This test was repeated at 2mv, 1mv, 0.8mv and 0.6mv with identical results of 2mv, 1mv, 0.8mv, and 0.6mv for both units.No logging data was available.Conclusion: no defect found.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): 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: 7740629
• MDR Text Key: 115918546
• Report Number: 3004593495-2018-00706
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169723160
• UDI-Public: 00643169723160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53401
• Device Catalogue Number: 53401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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-2317-2018
• Patient Sequence Number: 1