MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. EXTERNAL TEMPORARY PACEMAKER; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number 5348

Device Problem Inadequate User Interface (2958)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the external pulse generator (epg) results were "not ok".This was discovered prior to use.The epg was returned for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was unable to confirm the customer comment of the epg "results not ok".It was noted that the high rate cover was damaged and this was replaced.No other problem was found with the instrument and it was noted it was working ok.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.

Manufacturer Narrative

Product analysis: it was further reported that when the device was received and checked on sigma pace 1000 it was found that irrespective of turning any of the knobs, the readings would not change.Reconnected the connections on board and checked, it was working fine and the incoming test passed on the epg test system.No problem found with main board, interconnect flex.However due to intermittent issue or very rarely happening rate change, customer was informed that there is need for replacement of main board, battery flex, lead flex and interconnect flex for this type of intermittent issues.The device was returned unrepaired to the customer as requested.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: EXTERNAL TEMPORARY PACEMAKER
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• MDR Report Key: 10361789
• MDR Text Key: 201527692
• Report Number: 2183613-2020-00087
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• PMA/PMN Number: P820003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5348
• Device Catalogue Number: 5348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1661-2014
• Patient Sequence Number: 1