MAUDE Adverse Event Report: MEDTRONIC MEXICO EDMS II 25120 BECKER W/1-WAY VALVE; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	25120
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an external monitoring device.It was reported that there was a rupture with detachment of the device under the liquid collection sump.There was no reported impact to patient outcome.
Additional Manufacturer Narrative
No device has been returned for analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDMS II 25120 BECKER W/1-WAY VALVE
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15806099
• Report Number: 9612164-2022-04274
• Device Sequence Number: 17510857
• Product Code: GWM
• UDI-Device Identifier: 00763000333430
• UDI-Public: 00763000333430
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: 25120
• Device Catalogue Number: 25120
• Device Lot Number: 222559082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Unknown