MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR COOK CATHETER EVD 5 PK; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

Catalog Number NVVDC01ABRM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Unspecified Infection (1930); Therapeutic Response, Decreased (2271)

Event Date 12/25/2014

Event Type  Injury  

Event Description

It was reported to medtronic neurosurgery that a patient had a ventricular drain placed on (b)(6) 2014 due to a brain hemorrhage.According to the report, the patient developed a fever on (b)(6) 2014.On (b)(6) 2014, the patient's csf tested positive for serratia.It was reported that the patient's ventricular drain was removed on (b)(6) 2014 and the patient was discharged from the hospital to comfort care on (b)(6) 2015.According to the report, the patient died due to complications of meningitis and a brain bleed on (b)(6) 2015.

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.(b)(4).

Manufacturer Narrative

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

• Brand Name: VENTRICLEAR COOK CATHETER EVD 5 PK
• Type of Device: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 4529939
• MDR Text Key: 5360611
• Report Number: 2021898-2015-00064
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NVVDC01ABRM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: 01/20/2015
• Supplement Dates FDA Received: 09/18/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00072 YR
• Patient Weight: 81