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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE
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MEDTRONIC NEUROSURGERY BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE Back to Search Results
Model Number 26040
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was report that the external ventricular drainage (evd) clamps below the chamber were not functioning and cerebrospinal fluid was running into the collection bag.
 
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Brand Name
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
Common Device Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key8650656
Report Number2021898-2019-00213
Device Sequence Number16953105
Product Code GWM
UDI-Device Identifier00673978242323
UDI-Public00673978242323
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K984053
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/25/2022
Device Model Number26040
Device Catalogue Number26040
Device Lot Number214055003
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/22/2019
Initial Report FDA Received Date05/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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