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

Model Number 5318

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis found that the cable assembly and nuts were broken.(b)(4).

Event Description

The device was returned to the manufacturer for testing.It was analyzed and tested out of specification.No patient involvement or complications were reported as a result of this event.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5121528
• MDR Text Key: 27661283
• Report Number: 2183613-2015-01025
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/04/2015

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: 5318
• Device Catalogue Number: 5318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• 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