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

Model Number 5388

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: incoming functional testing passed.The battery contacts were contaminated and several parts were missing from the backside of the device.The device was inspected and battery contacts were cleaned.Final functional testing passed.The device passed all tests with no visual/electrical anomalies observed.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator (epg) was returned to the manufacturer for preventive maintenance.It was analyzed and was found to have internal contamination.There was no patient involvement.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8121866
• MDR Text Key: 129032024
• Report Number: 2183613-2018-00233
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2018

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: 5388
• Device Catalogue Number: 5388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/01/2018
• 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