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

Model Number	CODMAN 3000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient returned device tracking card with the comment "not working anymore.".
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: IMPLANTABLE DRUG INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11867047
• Report Number: 3015537318-2021-00014
• Device Sequence Number: 14308989
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2021

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 Expiration Date: 05/01/2016
• Device Model Number: CODMAN 3000
• Device Catalogue Number: AP03000H
• Device Lot Number: 515069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 05/17/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/07/2021; 06/24/2021
• 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: 63 YR
• Patient Weight: 96