MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM VENTRICULAR CATHETER, 35 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	26020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received reported the leak occurred with the drainage system.Please refer to manufacturer report # 2021898-2017-00355.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that after a ventricular drainage surgery, in the course of observing the patient's condition, the physician found that there was gas in the patient's lateral ventricle due to the drain pipe leaking on (b)(6) 2017.According to the report, the device was explanted and replaced with another device.Reportedly, the patient's status at the time of the report alive-no injury.
Additional Manufacturer Narrative
Additional information received reported the leak occurred with the drainage system.Please refer to manufacturer report # 2021898-2017-00355.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDM VENTRICULAR CATHETER, 35 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6677872
• Report Number: 2021898-2017-00354
• Device Sequence Number: 44210
• Product Code: JXG
• UDI-Device Identifier: 00643169498211
• UDI-Public: 00643169498211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 26020
• Device Lot Number: E11056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 08/08/2017; 08/08/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/25/2017; 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 60