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

Model Number 5388

Device Problems Display or Visual Feedback Problem (1184); Failure to Shut Off (2939); Inadequate User Interface (2958)

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

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis could not confirm customer comment that the epg) displayed an error code, or that the epg could not be turned off.Analysis confirmed the customer comment the epg setting could not be changed.The upper display was locked up.Rate, atrial, and ventricle numbers would not increase or decrease.The upper and lower case were broken.Two bail covers were broken.The ring cover was broken.Two bails were missing.The ring was missing.The keyboard was scratched.The liquid crystal display (lcd) was missing segments.The device was not repaired as it was at end of service.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) displayed an error code.It was also reported that the settings could not be changed or shut off.The epg returned into service.There was no patient involvement.

• 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
• 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: 14700936
• MDR Text Key: 296862565
• Report Number: 2183613-2022-00074
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5388
• Device Catalogue Number: 5388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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