MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 821676

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Hydrocephalus (3272)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

A patient with l4 myelomeningocele and shunted hydrocephalus.Several years ago, neurosurgery placed ventriculo-atrial catheter.Recently a ventriculoperitoneal (vp) shunt x-ray series was completed, ottawa subarachnoid hemorrhage (osh) head ct: enlarge ventricles in setting gradual worsening head aches over 3 months, likely due to shunt malformation causing hydrocephalus.Normal neuro exam reassuring with normal cranial nerves, strength, sensation, and neck range of motion.Neurosurgery consult: admission for shunt revision.A few days later, chest ct found a fragmented catheter.A few days later, once antibiotic (abx) course for infection not associated with this event, the patient went to cardiac cath lab for cardiology to retrieve fragmented piece from right pulmonary artery which was successful.

• Brand Name: CODMAN
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9452976
• MDR Text Key: 170322243
• Report Number: 9452976
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 821676
• Device Lot Number: CRNBZN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2019
• Event Location: Other
• Date Report to Manufacturer: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Weight: 79