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

Model Number 5392

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2015

Event Type  Injury  

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).

Event Description

It was reported that the external pulse generator turned off twice during a procedure without alerting that the battery was low.Another epg was used to finish the procedure.It was also noted that the epg required test and calibration.The epg was returned for repair.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: analysis was unable to confirm the customer comment that the unit turned off twice with no low-battery warning, the device was powered up on the bench for testing with the dc power supply, the low battery indication was at 2.4 volts and the device functioned as expected.Analysis further noted that the display wire was pinched, the wire insulation was not compromised however it was replaced as a preventive, one case screw was contaminated and the device was in need of the new shorting bar design.All found defective parts were replaced and all other identified issues were resolved.

Event Description

It was reported that the external pulse generator turned off twice during a procedure without alerting that the battery was low.Another epg was used to finish the procedure.It was also noted that the epg required test and calibration.The epg was returned for repair.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Further analysis was performed on the lcd module.Visual inspection indicated a depression in the red wire insulation from a component.The log did have evidence consistent with an intermittently shorted red wire.Conclusion: the conclusion is there were instances of a short from the lcd red wire causing erratic battery measurements to occur.

Manufacturer Narrative

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): 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: 5120208
• MDR Text Key: 27315674
• Report Number: 3004593495-2015-00228
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup,Followup,Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/11/2016
• Supplement Dates FDA Received: 12/09/2015; 06/09/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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
• Patient Outcome(s): Life Threatening; Required Intervention