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

Model Number	CODMAN 3000
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint suggests a catheter occlusion, which is a known complication of the codman 3000 as listed on the labeling.Catheter occlusion can occur due to a lack of flow from the pump, often when the pump is not refilled at the appropriate time interval.At the time of this report, it is unknown if the device is no longer being used because the course of therapy is completed or if therapy was interrupted.Intera has contacted the patient's physician in order to obtain confirmation of the refill intervals and drug regimen but does not have additional information at the time of this report.If additional information is received, it will be filed in a supplemental report.
Event or Problem Description
Device tracking card was returned and stated "no longer being used, not patent.".
Additional Manufacturer Narrative
Additional information and corrected codes provided in supplemental report.
Event or Problem Description
Further information received from patient: patient stated that the pump has been in place for over 10 years and that it has not been patent 'for a while.' treatment for colorectal cancer was not interrupted due to catheter patency issues, chemotherapy was received and after chemotherapy treatment, patient was having the pump filled with placebo solution to maintain catheter patency 'well past treatment'.At some point, the catheter 'sclerosed over' to her best memory.Patient stated she could not remember the exact nature of the adverse event.Patient could not remember if she was using heparinized saline or glycerin to maintain patency at the time of the adverse event.She had received treatment and is currently in remission for cancer.She stated that she did not wish to have the pump removed at this time because she does not want to undergo additional surgery, but is not currently in need of the chemotherapy at this time.

• 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: 11882788
• Report Number: 3015537318-2021-00021
• Device Sequence Number: 11116096
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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?: No
• 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: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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