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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Incontinence (1928); Loss of consciousness (2418); Cognitive Changes (2551)
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient was implanted in the beginning of 2018 due to hydrocephalus.In august, the patient began to feel tired and had to stay in bed for rest.The following month, the patient began experiencing levels of unconsciousness, ¿ignorance,¿ and incontinence.In october/november, the patient went to the hospital for a ct scan which showed that the patient¿s ventricle was larger than it was prior to implant.Following the scan, the doctor recommended a pressure adjustment to increase the flow rate.As of early november, the patient was hospitalized with the same issues reported above.It was noted the manufacturer representative was to go to the hospital and adjust the device.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported there were no external/environmental/patient factors identified that may led to the reported issues.It was stated the patient¿s issues resolved following an adjustment of the device.
 
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Brand Name
UNKNOWN STRATA VALVE/SHUNT
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8069325
MDR Text Key127090669
Report Number2021898-2018-00530
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/04/2019
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
Device Operator No Information
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/02/2018
Initial Date FDA Received11/14/2018
Supplement Dates Manufacturer Received12/09/2018
Supplement Dates FDA Received01/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age67 YR
Patient Weight75
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