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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA BURR HOLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY STRATA BURR HOLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42836
Medical Device Problem Code Mechanics Altered (2984)
Health Effect - Clinical Codes Loss of consciousness (2418); Ambulation or Postural Difficulties (2544)
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 that the patient's shunt had been turning off and on, on its own.It was clarified that the settings had been changing.The patient had been experiencing issues with their balance and gait.They had also experienced some passing out as well.
 
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Brand Name
STRATA BURR HOLE VALVE
Common Device Name
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key9801325
Report Number2021898-2020-00089
Device Sequence Number13605501
Product Code JXG
UDI-Device Identifier00613994380098
UDI-Public00613994380098
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K083076
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/06/2020
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 Date06/30/2017
Device Model Number42836
Device Catalogue Number42836
Device Lot NumberD63155
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/04/2020
Initial Report FDA Received Date03/06/2020
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 Other;
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