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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN 3000 IMPLANTABLE DRUG DELIVERY PUMP

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CODMAN & SHURTLEFF CODMAN 3000 IMPLANTABLE DRUG DELIVERY PUMP Back to Search Results
Model Number CODMAN 3000
Device Problem No Flow (2991)
Patient Problem Obstruction/Occlusion (2422)
Event Date 01/01/2007
Event Type  malfunction  
Manufacturer Narrative
Based on the age of the complaint, the exact course of events leading up to the root cause cannot likely be determined. The exact explant date is unknown. It is unknown if this complaint was previously reported to codman at the time of the event. The medical oncologist is no longer in active practice, so further details cannot be obtained from medical record. The discussion from the patient suggests a possible catheter occlusion blocked the catheter pathway to the artery. Catheter occlusion is a known complication to hepatic artery infusion therapy. Catheter occlusion can occur if the pump refill schedule is not maintained correctly and the pump runs dry or empties over the course of the refill period. Since the patient stated the pump was no longer needed, it is unclear if the pump was deliberately not refilled after therapy was completed and then later explanted, or if therapy was interrupted.
 
Event Description
The patient called the clinical call line in response to the device tracking mailing to state that his codman pump had been previously removed. He stated that the pump was "plugged up," but no longer needed, so it was removed in 2007.
 
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Brand NameCODMAN 3000
Type of DeviceIMPLANTABLE DRUG DELIVERY PUMP
Manufacturer (Section D)
CODMAN & SHURTLEFF
325 paramount drive
rayhnam MA 02767
Manufacturer (Section G)
INTERA ONCOLOGY
65 william street
suite 200
wellesley MA 02481
Manufacturer Contact
sarah lapp
65 william street
suite 200
wellesley, MA 02481
7814895724
MDR Report Key11828958
MDR Text Key253465962
Report Number3015537318-2021-00006
Device Sequence Number1
Product Code LKK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P890055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCODMAN 3000
Device Catalogue NumberAP03000H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2001
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/14/2021 Patient Sequence Number: 1
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