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

Model Number CODMAN 3000

Device Problems Break (1069); Migration (4003)

Patient Problems Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

Insufficient 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.Additional attempts at contact are planned.If additional information is received, a supplemental report will be filed.A review of the device history record was conducted.No nonconformances for the production lot were noted and the device met all specifications as manufactured.

Event Description

Patient returned device tracking card with the comment "not working anymore.".

Event Description

Phone dialog with a patient family member was conducted on (b)(6) 2021: family member described the complaint as a catheter dislodgment, which occured approximately 3 years ago.

Event Description

Information obtained from health care provider stated patient developed hematoma found at the tip of the hepatic pump catheter as found via mri.Hepatic angiography with a vascular stent was placed on the hepatic artery.

Manufacturer Narrative

Additional information was provided by the healthcare provider and added to this supplemental report.Hematoma and migration are known complications with use of the codman 3000 as stated on the labeling.

• Brand Name: CODMAN 3000
• Type of Device: IMPLANTABLE DRUG INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11867047
• MDR Text Key: 255130413
• Report Number: 3015537318-2021-00014
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (y/n): Y
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: CODMAN 3000
• Device Catalogue Number: AP03000H
• Device Lot Number: 515069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 96