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

Model Number 82-1676

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Admission from the emergency department presents with new onset head ache, nausea & 1 episode vomiting without altered mental status concerning for shunt malfunction.Head ct impression: new discontinuity of shunt at the level of neck, with distal portion of catheter retracted and projecting over right ventricle region.Ct chest + for pulmonary (pulm) artery embolization of ventriculoatrial shunt fragments, with 2 discrete shunt fragments 1 in right and left main pulm artery extending into left descending pulm artery branch & additional discrete fragment within left descending pulm artery branch.Lungs clear.A few days later, the patient was sent to operating room for shunt replacement (vps) & then went for retrieval of shunt fragments in pulm artery.Did well no complications.

• Brand Name: CODMAN HOLTER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9450896
• MDR Text Key: 170291915
• Report Number: 9450896
• 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 Model Number: 82-1676
• Device Catalogue Number: 821676
• Device Lot Number: 185640
• Was Device Available for Evaluation?: Yes
• 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: 4745 DA
• Patient Weight: 36