MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	3.0PED
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/04/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the manual or instructions (ifu) do not clearly describe how to use the medical device.It was reported that the patient had symptoms of bradycardia.Patient was premature male (b)(6) kg and the patient's mother had a known infection.The customer reported that the device was placed improperly.It was reported that later at an unspecified date and time the patient died, and the death was unrelated to this device and event.The customer noted that the product was destroyed.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6898917
• Report Number: 2936999-2017-05504
• Device Sequence Number: 13804906
• Product Code: JOH
• UDI-Device Identifier: 30884522026691
• UDI-Public: 30884522026691
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2020
• Device Model Number: 3.0PED
• Device Catalogue Number: 3.0PED
• Device Lot Number: 15C0499JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 1