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

Model Number	CODMAN 3000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	12/20/2005
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact explant date is not known and is estimated.Sufficient information to make a determination of the adverse event is not available at this time.Intera has contacted the physician's institution in order to obtain more information about the nature of the product problem, but has not received additional information at the time of this report.If additional information is received, a supplemental report will be filed.
Event or Problem Description
Patient called clinical call line in response to device tracking mailing stating that the "pump was blocked and bothering her." patient states pump was removed 4 years ago.
Event or Problem Description
Additional information was provided from patient's health care provider.The health care provider stated that the patient had a codman 3000 drug delivery pump implanted for hepatic arterial infusion.They stated that five days after implantation, patient had post-surgery abnormal hepatic flow.A diagnostic arteriogram found that the common hepatic artery was dissected and occluded.Vascular dissection and subsequent occlusion/thrombosis may occur due to malposition of the catheter in artery during implant.Vessel thrombosis is a known procedural complication as listed on the labeling of the codman 3000.Heparinized saline was being administered in the pump at the time of the adverse event.Explant date was not provided.
Additional Manufacturer Narrative
Updated information based on feedback from the patient's healthcare provider.Blank fields in the mdr form represents unknown information.

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTABLE DRUG INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11838720
• Report Number: 3015537318-2021-00011
• Device Sequence Number: 4634742
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2017
• 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): 07/07/2021

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: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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
• Patient Age: 54 YR
• Patient Weight: 59