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

Model Number 53401

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis: it was determined on analysis that the external pulse generator (epg) tested out-of-specification as it failed incoming functional test (0.4 mv ventricular sensitivity sense).The main printed circuit board (pcb) was out of specification electrical.The epg also failed final functional tests "output dial".The encoder assembly was out of specification electrical.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.

Event Description

The external pulse generator (epg) was returned for preventative maintenance and subsequently tested out of specification during man ufacturers analysis.There was no patient involvement.

Manufacturer Narrative

Product analysis update: further analysis of the external pulse generator (epg) was performed.The main board was assembled into a g olden unit and failed ventricular sensitivity sense test on automated test console.The unit was powered up on the bench whereupon ventricular sensitivity sense tested within tolerance requirement using analyzer tool with the external pulse generator (epg).Sensitivity sensing test was performed on a known good unit with the same result.The device was powered on/off multiple times with no errors observed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: TEMPORARY EXTERNAL PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18110030
• MDR Text Key: 328491655
• Report Number: 2182208-2023-03362
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169723160
• UDI-Public: 00643169723160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 53401
• Device Catalogue Number: 53401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1