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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. CODMAN HOLTER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 82-1676
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 08/06/2019
Event Type  malfunction  
Event Description
A young patient with history of right porencephalic cyst with communication to his ventricular system & subsequent shunted hydrocephalus. In past, he failed both ventriculoperitoneal shunt (vps) & ventriculopleural shunt due to pseudocyst formation/malabsorption. Most recent shunt revision was conversion to right side ventriculoatrial shunt. Pt was evaluated through physical medicine clinic & had x-rays to eval for potential scoliosis, which incidentally revealed that ventriculoatrial shunt had fractured with tubing dislodged into his left pulmonary artery. Branch. Echo showed fragment of catheter in left pulmonary artery. A few weeks later, cardiology removed the fragmented piece successfully in cath lab.
 
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Brand NameCODMAN HOLTER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key9450849
MDR Text Key170291474
Report Number9450849
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number82-1676
Device Catalogue Number821676
Device Lot NumberCMMC33
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Event Location Other
Date Report to Manufacturer12/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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