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

Model Number UNKNOWN-S

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Fall (1848); Hematoma (1884); Hemorrhage, Subdural (1894); Incontinence (1928); Seizures (2063); Encephalitis (2429); Ambulation Difficulties (2544)

Event Date 01/01/2019

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 underwent ventriculoperitioneal (vp) shunt surgery in (b)(6) 2018 for normal pressure hydrocephalus.It was stated that the shunt was malfunction during follow-up visits.Last year, the patient fell from a convulsion and developed bilateral subdural hematoma.The patient underwent bilateral mini craniotomy.Incidentally, the patient developed auto immune encephalitis for which they were on immunotherapy and steroids.The neurosurgeon was now saying to undergo revision vp shunt surgery or do daily correction of pressure by the adjustment system.Additional information received reported that the patient was deteriorating further.It was stated they were not able to walk or get up, bedridden, lost bladder control, not able to spit, and difficulty in swallowing.A lumber puncture was performed, and symptoms improved dramatically.It was noted they had tested twice in the last 10 days.The doctors concluded that the vp shunt was malfunctioning, and the patient was having a revision on (b)(6) 2020.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10043417
• MDR Text Key: 190602564
• Report Number: 2021898-2020-00138
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 04/27/2020
• 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: 77 YR