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

Model Number 5392

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: it was determined at analysis that the microprocessing unit board failed its incoming test.It was further noted that the hanger assembly was broken and the patient cable was detached from the connector.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) was returned for preventive maintenance and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Analysis summary: further analysis was requested on the external pulse generator's main board.During this analysis the ventricular pace output noise measured within acceptable measurements (37.56 mv).Tier 2 analysis concluded that the high measurement on the automated test console was due to noise from the automated test console combining with the device noise and that the board was functioning as designed and was not out of specification.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: 10125750
• MDR Text Key: 194303487
• Report Number: 3004593495-2020-00592
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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: 05/14/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1