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

Model Number	CODMAN 3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the complaint is not confirmed.Based on the age of the complaint, a full investigation may not be able to be completed.It is also unknown if this complaint was previously reported to codman.If further information is obtained, it will be filed in a supplemental report.The codman 3000 is indicated for hepatic artery infusion for metastatic cancer, pain, or spasticity therapy.At this time it is unknown what indicate this specific pump was used for.A number of factors can influence the ability of the pump to deliver pain relief: the drug type and concentration, the patient's psychological response in switching from oral opioids to intrathecal drug delivery, the suitability of a drug delivery pump vs other treatments (such as spinal cord stimulation), catheter migration, altitude changes due to travel, physical impact to the implant site, exposure to higher temperatures through use of heating pads/blankets or use of saunas/hot tubs, or pump malfunction.
Event or Problem Description
Patient returned device tracking card stating "please make sure, the pump is working.I got the pump, which never worked." patient wrote that pump was previously explanted.

• 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: 11917084
• Report Number: 3015537318-2021-00024
• Device Sequence Number: 3426326
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• 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): 06/01/2021

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: 05/03/2021
• Initial Report FDA Received Date: 06/01/2021
• 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