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

Model Number 5392

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591)

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

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product problem: analysis confirmed the customer comment of a generated error via the error log and attributed it to the main printed circuit board being out of specification in an electrical manner.It was also noted that the keyboard was scratched.All found defective parts were replaced and all other identified issues were resolved.(b)(4).

Event Description

It was reported that while in use on a pacer-dependent patient the external pulse generator generated an "error, device needs to be restarted" message.It was noted that there was no affiliated error number with the message.It was also noted that the heart rate was still showing spikes on the patient monitor when this occurred.The generator was changed out immediately when the error was noticed, and it was not noted what all of the settings had been.The generator was returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Further analysis was performed on the main printed circuit board assembly.Visual inspection revealed no anomalies.Bench analysis found that the device powered up normally and passed all functional tests.While the device was running an error appeared on the display, the error appeared more often when the device was placed in an oven at 70 degrees celsius.The device did not fail at cold temp.The die stack was replaced, the device ran for 12 hours in the oven with no failures.The error was documented in the error log.Conclusion: the reported event was confirmed, the die stack was defective.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.

• 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: 5278907
• MDR Text Key: 33074371
• Report Number: 3004593495-2015-00353
• Device Sequence Number: 1
• Product Code: DTE
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

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: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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): Required Intervention