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

Model Number 42856

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problems Headache (1880); Therapeutic Effects, Unexpected (2099); Visual Impairment (2138); Malaise (2359); Lethargy (2560)

Event Date 05/01/2019

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's distal catheter had fractured off the shunt.Additional information received stated that 2 weeks ago, it was known by the patient that the reservoir had shattered.It was also known that the patient went in for an adjustment with their doctor and stated that they went from a 1.5 to a 1.0 to then a 0.5.Within a time frame of feeling sick, they went back, and the shunt had changed from 0.5 to 1.0.It was noted the patient has had six shunts/revisions.

Manufacturer Narrative

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

Event Description

Additional information received reported that the valve was adjusted to the setting of 0.5 on (b)(6) 2019, and between then and (b)(6) 2019, the valve had set itself back to 1.0.The patient had a return of symptoms along with other symptoms of being very lethargic.Their head pressure had returned as well as vision problems.

Manufacturer Narrative

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

Event Description

Additional information received reported that in (b)(6) 2019, a shunt series showed a possible kink in the distal catheter, but nothing was done to remedy it because the patient had a second shunt placed in (b)(6) 2019.It was stated that because the patient had bilateral shunts, they were told they would have to wait until (b)(6) 2019 to have the fractured one removed.

• Brand Name: STRATA II VALVE, SMALL
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9172130
• MDR Text Key: 161737581
• Report Number: 2021898-2019-00359
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2019

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: Health Professional
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 10/29/2019
• Supplement Dates FDA Received: 10/28/2019; 10/30/2019
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 86