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

Model Number 42365

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage, Cerebral (1889); Therapeutic Effects, Unexpected (2099); Coma (2417); Loss of consciousness (2418); Sleep Dysfunction (2517)

Event Date 04/03/2019

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 was implanted with a pressure regulating shunt on (b)(6) 2019 due to hydrocephalus.After the surgery, the patient had been hospitalized in the surgical hospital for treatment.After the operation, the patient's pressure position was adjusted to 1.5, and there was excessive drainage and cerebral hemorrhage; however, when the pressure position was adjusted to 2.0, the ventricle was too large.Since (b)(6) 2019, the patient was in a coma.It was noted the patient was not in a come pre-operatively.At present, the patient was still in the surgery hospital, and the family said that there had been a blockage.

Manufacturer Narrative

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

Event Description

Additional information received reported a pressure adjustment was performed to resolve the issue; however, the patient's current status was unconscious, unable to eat, and unable to sleep.It was stated the patient's hydrocephalus was caused by an aneurysm surgery.Then, the shunt surgery was performed.

• Brand Name: STRATA NSC VALVE, REGULAR
• 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: 8680585
• MDR Text Key: 147388410
• Report Number: 2021898-2019-00226
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033850
• 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,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42365
• Device Catalogue Number: 42365
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• 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
• Patient Age: 49 YR
• Patient Weight: 70