MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. EXTERNAL TEMPORARY PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 5348

Device Problem Calibration Problem (2890)

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

Event Type  malfunction  

Event Description

It was reported that the external pulse generator (epg) was returned for preventative maintenance and subsequently tested out-of-spe cification during manufacturers analysis. there was no patient involvement.

Manufacturer Narrative

Product analysis: it was determined during analysis of the external pulse generator (epg), the parameters were out of tolerance during incoming testing.The frequency potentiometer could be turned but the frequency could not be changed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis update: it was recommended that the external pulse generator be decommissioned.The device was returned to the customer unrepaired.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.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: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• Manufacturer (Section G): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14355178
• MDR Text Key: 291406279
• Report Number: 2183613-2022-00056
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P820003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• 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: 05/03/2022
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• 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