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

Model Number 5348XW

Device Problems Mechanical Problem (1384); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis of the device was able to confirm the customer comment of a power button issue.Analysis also noted that the upper case, keypad, o-ring, ring cover, cover bail and control knob were all damaged and subsequently repaired.All functions and performance tests were performed on the test console to confirm that the operation was normal.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the power button on the external pulse generator was intermittent and was difficult to power on and off.The device has been returned for service.There was no patient involvement.

• 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
• 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: 10165240
• MDR Text Key: 195609039
• Report Number: 2183613-2020-00066
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P820003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5348XW
• Device Catalogue Number: 5348XW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2020
• 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