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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 91503
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/26/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported the patient¿s abdomen was covered with fluid and there was a suspected infection about 3 months after implant.The device was explanted.A culture indicated there were inflammatory changes and an epidermis infection.The patient¿s status was noted as alive-no injury.
 
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Brand Name
VENTRICULAR CATHETER WITH BIOGLIDE, STANDARD, 23 CM
Common Device Name
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key7144192
Report Number2021898-2017-00667
Device Sequence Number1108934
Product Code JXG
UDI-Device Identifier00643169466289
UDI-Public00643169466289
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K951258
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 12/22/2017
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? No
Operator of Device Health Professional
Device Expiration Date03/31/2021
Device Model Number91503
Device Catalogue Number91503
Device Lot NumberE14137
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/27/2017
Initial Report FDA Received Date12/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age28 YR
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