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

Model Number	CODMAN 3000
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/01/2007
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11828958
• Report Number: 3015537318-2021-00006
• Device Sequence Number: 11051235
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2007
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CODMAN 3000
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention