MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER, STANDARD, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 43522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dysphasia (2195); Loss of consciousness (2418); Ambulation Difficulties (2544); Lethargy (2560); No Code Available (3191)

Event Date 04/24/2019

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 was diagnosed with hydrocephalus in or about (b)(6) 2018.After going various options, their medical team recommended surgery and the insertion of a shunt to drain fluid from their head.The surgery took place the morning of (b)(6) 2019.The procedure took approximately 2 hours, during which a ventricle and peritoneal catheter from the manufacturer were inserted in accordance with standard practice and procedure.While in post-op care the same day as the surgery, the patient became lethargic and lost consciousness.They were subsequently taken for a ct scan where it was discovered that the shunt was draining fluid far too rapidly.As a result, they were rushed into a further surgery where the shunt was clamped off to prevent further drainage, however, that was not before the patient suffered what appeared to be significant brain damage including, but not limited to, an inability to walk, paralysis of their vocal cords, an inability to eat among other things.

• Brand Name: PERITONEAL CATHETER, STANDARD, 90 CM
• 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 ; 9496801345
• MDR Report Key: 9628335
• MDR Text Key: 179545925
• Report Number: 2021898-2020-00045
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169497122
• UDI-Public: 00643169497122
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K792005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 43522
• Device Catalogue Number: 43522
• Device Lot Number: E61550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Date Device Manufactured: 03/16/2019
• 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; Required Intervention; Disability
• Patient Age: 77 YR