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

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.

• 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 Key: 8069325
• MDR Text Key: 127090669
• Report Number: 2021898-2018-00530
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• 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 Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 12/09/2018
• Supplement Dates FDA Received: 01/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 75