MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42866
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a valve used during a procedure.It was reported that the product was damaged.It was noted that there was a valve assembly failure.There was no reported delay to the procedure.There was no reported impact to the patient.
Additional Manufacturer Narrative
This event took place in (b)(6).No products have been returned to medtronic for analysis.(b)(4) are applicable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA®
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13904523
• Report Number: 2021898-2022-00077
• Device Sequence Number: 4303258
• Product Code: JXG
• UDI-Device Identifier: 00613994804648
• UDI-Public: 00613994804648
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/25/2022

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: 05/31/2019
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E12409
• 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: 03/24/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male