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

Model Number 5348

Device Problem Inadequate User Interface (2958)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis was able to confirm that the epg could not be used as normal noting that there was no sensing.The lead connection flex assembly board was replaced.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) could not be used normally after it was turned on.The epg was returned for service.There was no patient involvement.

Manufacturer Narrative

Corrections: initial reporter name and address.Report source.If information is provided in the future, a supplemental report will be issued.

• 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: 9684396
• MDR Text Key: 178360470
• Report Number: 2183613-2020-00023
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P820003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 01/13/2020
• Date Manufacturer Received: 03/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2004
• 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