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 Hematoma (1884); Hemorrhage, Subdural (1894); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's wife questioned if the device was actually working for the patient's normal pressure hydrocephalus.It was noted that the patient's wife thought the instrumentation to check the device seemed "hinky," and they were living a nightmare.It was noted they wanted to know what was wrong with the valve that caused the recall and what was done to fix it.

Manufacturer Narrative

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

Event Description

Additional information received stated the patient was falling down and was making no progress despite having their device.It was stated they were going to see a different neurologist.

Manufacturer Narrative

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

Event Description

Additional information received reported that the patient's status was the same as before the shunt surgery.They had very good results with another manufacturer's device, but they needed a shunt revision.The patient was implanted with the manufacturer's device, and it is like they had nothing.The setting was at 0.5.The doctor had difficulty in setting the device after surgery and could not get repeat-ability.The doctor set the device at the middle setting after surgery, but first reading showed it at 0.5.

Manufacturer Narrative

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

Event Description

Additional information received reported that the patient's husband had their shunt since (b)(6) 2019, and they couldn't stand up without falling.

Manufacturer Narrative

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

Event Description

Additional information received reported that the patient's husband has had 2 subdural hematomas with their shunt from falling.

• 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: katcha taylor ; 9775 toledo way; irvine,ca, MN 92618 ; 9496801345
• MDR Report Key: 8650326
• MDR Text Key: 146380636
• Report Number: 2021898-2019-00209
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• 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
• Date Manufacturer Received: 01/26/2020
• 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): Other