MAUDE Adverse Event Report: CODMAN & SHURTLEFF ARROW MODEL 3000; IMPLANTED DRUG DELIVERY PUMP

Model Number	MODEL 3000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/01/1998
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient states that device was explanted due to irritation.Exact explant date is unknown and estimated for this report.Irritation from the pump could be due to irritation from the pump surface in the pump pocket, the chemotherapy medication, or patient awareness of the implant device.Contraindications for the chemotherapy drugs are listed on the drug label as stated by the current codman 3000 instructions.Given the age of the incident and the discussion with the patient, it is undetermined the exact cause.The event occured in 1998, at which time arrow was the manufacturer of the device.It is unknown if this complaint was reported to arrow at the time of the event.Due to the age of the complaint, the device history record could not be reviewed.Intera does not have any trend in complaints for codman or arrow model 3000 devices that suggest a systemic issue of the pump causing irritation.
Event or Problem Description
Patient responded to device tracking mailing stating that pump was removed 4 months after implant because it irritated her.She stated she received chemotherapy for the 4 months and is currently disease free.Implant date was (b)(6) 1998.

• Brand Name: ARROW MODEL 3000
• Common Device Name: IMPLANTED DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11829061
• Report Number: 3015537318-2021-00007
• Device Sequence Number: 13741579
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 1998
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: MODEL 3000
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2021
• 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