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

Model Number 42856

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6).It was reported that once the valve was implanted, it would not drain.

• Brand Name: STRATA II VALVE, SMALL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9125924
• MDR Text Key: 161736593
• Report Number: 2021898-2019-00348
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: E58211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1