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

Model Number UNKNOWN-S

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Paralysis (1997); Seizures (2063); Swelling (2091)

Event Date 09/10/2015

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 at the end of (b)(6).About ten days after implant, the patient began experiencing seizures.A right ct scan showed brain swelling and there was low pressure in the head.The cause was not known.The patient was hospitalized for two weeks and experienced ¿about 20 seizures a day,¿ with varying severity.Both an increased heart rate and memory loss were noted.Reportedly, the device was ¿shut off¿ and the patient¿s seizures decreased to 1-2 a day.The seizures stopped after 3-4 weeks of hospitalization.The patient could not move their left arm and their left leg was reportedly paralyzed.The patient left the hospital in october and their headaches came back that same month.When the device was set to be turned ¿on,¿ it was already ¿on.¿ it was stated the patient reportedly had not been around magnets.Later in (b)(6), the patient would experience headaches.A dye test indicated that the device was ¿not working.¿ it was determined the lumbar catheter had disconnected from the valve, though it was unknown when that had occurred.The device was explanted in (b)(6) and the patient¿s status was stable.

Manufacturer Narrative

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

Event Description

Additional information received reported the patient was evaluated in (b)(6) 2015 at the hospital for ¿bilateral subdural collection with associated seizure activity in the setting of intracranial hypotension thought to be related to recent shunt placement with csf over drainage.¿ the patient had been implanted with a lumboperitoneal shunt.

Manufacturer Narrative

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

Event Description

Additional information received reported the patient's device was not working properly causing them multiple medical issues.It was stated the shunt was installed in 2015.It was noted the patient had a second shunt put in later; however, it is unclear whether the second shunt was referring to the shunt that was installed in 2015 or another one.The patient had a seizure shortly after having the second shunt implanted.It turned out the patient had swelling of the right side of the brain.

Manufacturer Narrative

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

• 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: 7058265
• MDR Text Key: 92901600
• Report Number: 2021898-2017-00589
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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; Disability
• Patient Age: 53 YR
• Patient Weight: 91