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

Model Number 5392

Device Problems Battery Problem (2885); Unexpected Shutdown (4019)

Patient Problems Cardiopulmonary Arrest (1765); Injury (2348)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the physician was using the external pulse generator (epg) to treat a patient.The patient was pacemaker dependent and was being transferred from the operating room(or), to intensive care unit (icu), post heart surgery.The physician observed the unit had full bars upon new battery insertion and also before the transfer(post chest closure) to icu.Approximately 10 minutes passed then, during transfer, the red, low battery light emitting diode (led) suddenly lit up and then the unit shut off.The patient required cardiopulmonary resuscitation(cpr), the patient recovered.Immediately after the incident, clinicians were able to recreate the pacemaker failure the pacemaker showed full bars and then shutdown.Further attempts were made to recreate these incidents in our shop without success.However, it was noticed when slowly adjusting the voltage on a dc generator connected to a pacemaker, there was a delay in the pacemakers battery power indicator updating the change in voltage (~30sec to 4+ minutes).It was acknowledged that this was not an ideal test setup, however, could this delay be a contributing factor.Another epg was used to treat the patient.The epg is expected to return for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: the analysis could not confirm the customer comment of the red, low battery light emitting diode (led) suddenly lit up and then the unit shut off.It was also determined at analysis that errors occurred multiple times, the main printed circuit board was out of specification electrical.The hanger assembly was broken.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10389927
• MDR Text Key: 202348079
• Report Number: 3004593495-2020-00841
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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: 09/10/2020
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention