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

Model Number 5388XG

Device Problems Use of Device Problem (1670); Calibration Problem (2890); Inadequate User Interface (2958)

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

Event Date 01/21/2021

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 menu of the external pulse generator (epg) could not be accessed.The epg is expected to return for service.There was no patient involvement.

Manufacturer Narrative

Product analysis: analysis was able to confirm the customer comment that the menu of the external pulse generator (epg) could not be accessed.It was noted that no information or settings were visible on the lower liquid crystal display (lcd) and that the the lcd and main printed circuit board (pcb) were defective.Contamination was observed on the battery chamber, release mechanism and associated parts.The epg was not repaired as it was no longer serviceable.The epg was shipped back 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.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

It was further reported that the epg was returned for service.

• Brand Name: DUAL CHAMBER 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
• MDR Report Key: 11271732
• MDR Text Key: 230023822
• Report Number: 2183613-2021-00019
• 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
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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: Health Professional
• Device Model Number: 5388XG
• Device Catalogue Number: 5388XG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1