MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LUMBOPERITONEAL SHUNT KIT, WITH INTEGRAL PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 44430

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894); Coma (2417)

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 in a coma.

Manufacturer Narrative

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

Event Description

Additional information received reported that the patient couldn't have an mri due to another implanted device.It was stated that the patient's shunts were working, and the doctors were trying to adjust both of them to get their treatment just right.They had recently experienced subdural hematomas.The doctor stated that this was caused by over-drainage of the shunt, and they were trying various settings to get him to drain properly.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT, WITH INTEGRAL PERITONEAL CATHETER
• 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: 9042594
• MDR Text Key: 160076499
• Report Number: 2021898-2019-00336
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 44430
• Device Catalogue Number: 44430
• Device Lot Number: E44808
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Date Device Manufactured: 04/03/2018
• 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): Other