MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number UNKNOWN-C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 10/16/2016

Event Type  malfunction  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.The instructions for use (ifu) that accompany the device indicate local and systemic infections are not uncommon with any shunting procedure.They are most usually due to organisms that inhabit the skin, particularly staphylococcus epidermidis.However, other pathogens circulating in the blood stream may colonize the shunt and, in the majority of patients, require its removal.A review of the manufacturing and sterilization records was not possible as no lot number was provided.All catheters are 100% inspected at the time of manufacture.

Event Description

It was reported to medtronic neurosurgery that the patient had surgery on (b)(6) 2016 due to a brain tumor with hydrocephalus.According to the report, the device was found to have malfunctioned and was not working properly.It was reported that the patients symptoms did not improve after the surgery and the patient experienced bleeding and developed an infection.Reportedly, the patient is doing well.

Manufacturer Narrative

Additional information received clarified there was no allegation of malfunction against the catheter.The catheter remained implanted.

Manufacturer Narrative

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

• Brand Name: UNKNOWN CATHETER
• 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: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6104350
• MDR Text Key: 59977844
• Report Number: 2021898-2016-00414
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 66 YR
• Patient Weight: 75