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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE
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MEDTRONIC NEUROSURGERY EDM LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE Back to Search Results
Model Number 27304
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 09/30/2019
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 reported that during a lumbar drain placement, the catheter met resistance while trying to reposition and advance it.It became clear that the catheter had become stuck and likely had sheared.As such, the doctor removed the needle and catheter and confirmed that approximately 4-5 cm of the catheter was retained in the patient.
 
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Brand Name
EDM LUMBAR DRAINAGE KIT
Common Device Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key9347421
Report Number2021898-2019-00414
Device Sequence Number16829176
Product Code GWM
UDI-Device Identifier00673978246055
UDI-Public00673978246055
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K802100
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/20/2019
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 Date02/29/2024
Device Model Number27304
Device Catalogue Number27304
Device Lot Number217395078
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2019
Initial Report FDA Received Date11/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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