MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY INNERVISION SNAP SHUNT VENTRICULAR CATHETER KIT; CATHETER, VENTRICULAR

Catalog Number 27298

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.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 Description

It was reported to medtronic neurosurgery through a legal claim letter that the device had failed and the patient suffered a brain hemorrhage and permanent and debilitating injuries.

Manufacturer Narrative

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

• Brand Name: INNERVISION SNAP SHUNT VENTRICULAR CATHETER KIT
• Type of Device: CATHETER, VENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 5882403
• MDR Text Key: 52312750
• Report Number: 2021898-2016-00283
• Device Sequence Number: 1
• Product Code: HCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 27298
• Device Lot Number: D62266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 84