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); Headache (1880); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient went to a follow-up appointment on (b)(6) 2018 with complaints of a pressure-like sensation in their head.The patient complained of incisional pain from their shunt replacement surgery, however, noted that the pressure was a different sensation from their incisional pain.A ct scan of their head was obtained which did not show much change in their ventricle size when compared to previous imaging.The doctor adjusted the patient's setting from 1.5 to 0.5.They checked their shunt 2 times after the adjustment and got 0.5 both of those times.On (b)(6) 2019, the patient again went in for a follow-up appointment due to dealing with daily headaches.It was stated the headaches at times could become quite severe.They were taking a generic form of excedrin on a daily basis.The patient also noted they had felt more sleepy since the shunt was put in.A ct scan of their head was performed and showed a decrease in the size of their ventricles.There was no evidence of subdural, subarachnoid, or intraventricular blood.The shunt was then adjusted to 1.0 to see if that improved their headaches.

• 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: 8927145
• MDR Text Key: 156948070
• Report Number: 2021898-2019-00320
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2019

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 52