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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE
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MEDTRONIC NEUROSURGERY EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE Back to Search Results
Model Number 27302
Medical Device Problem Codes Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
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 while the ¿guide¿ was being removed during the procedure, it created holes inside the catheter, leading to the leaking of cerebrospinal fluid.It was indicated there were no symptoms associated with the event.
 
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Brand Name
EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT
Common Device Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key7244206
Report Number2021898-2018-00063
Device Sequence Number165027
Product Code GWM
UDI-Device Identifier00673978246031
UDI-Public00673978246031
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
K984053
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 02/06/2018
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 Date09/30/2019
Device Model Number27302
Device Catalogue Number27302
Device Lot Number212510047
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/24/2018
Initial Report FDA Received Date02/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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