MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION CODMAN BACTISEAL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 82-3073

Device Problems Obstruction of Flow (2423); Positioning Problem (3009)

Patient Problems Pain (1994); Brain Injury (2219); Respiratory Failure (2484); Convulsion/Seizure (4406)

Event Date 10/19/2007

Event Type  Injury  

Event Description

Reporter calling, stating that her daughter has had numerous health problems and reporting medical cover-ups by multiple healthcare personnel and healthcare organizations ever since her daughter was implanted with nervous system shunts and catheters.Reporter states her daughter has had "over 110 high-dose ct scans" of her brain.Reporter also states she has contacted medtronic regarding her concerns but was retaliated against and "they are threatening to sue me." reporter states cover-ups by healthcare personnel include a fall that her daughter suffered while being treated in the emergency room, an expired device that was implanted in her daughter, position problems with the catheter, shunts not draining correctly as well as a blocked shunt, and brain damage including encephalomalacia.Reporter states her daughter has suffered "seizures and head pain" and even respiratory failure in 2022.Reporter states she has concerns that "they have never run a shuntogram".Reporter states the device vibrates and causes her daughter pain and that the companies "need to be held responsible." reference reports: mw5119302, mw5119303.

• Brand Name: CODMAN BACTISEAL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 17309505
• MDR Text Key: 319050944
• Report Number: MW5119304
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/01/2008
• Device Catalogue Number: 82-3073
• Device Lot Number: CHDCZ9
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 159 KG