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

Model Number	CODMAN 3000
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date is estimated based on the information reported.Based on the age of the complaint and the fact that the device was discarded after explant, a full investigation cannot be completed as the device is not available for analysis.It is undetermined as the exact root cause of the complaint.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, pump flow rate, the suitability of a drug delivery pump vs other treatments (such as spinal cord stimulation), catheter migration or malfunction, 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 responded to device tracking mailing by calling the clinical call line to state her pump had been removed 9 months after implant because it provided 'no pain relief.' implant date was (b)(6) 2006.
Event or Problem Description
Explanting physician returned written correspondence stating codman pump had an obstructed catheter and was explanted in (b)(6) 2016.Patient was experiencing increased back and leg pain.Medication course was intrathecal morphine and bupivacaine.
Additional Manufacturer Narrative
Returned information from explanting physician was received (b)(6) 2021, so a supplemental is being filed.Explant date and patient information are updated/clarified.The codman pump is only indicated for morphine and not bupivacaine.Catheter migration and subsequent obstruction) is a known risk documented in the labeling of the codman 3000.

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTED DRUG INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11838701
• Report Number: 3015537318-2021-00010
• Device Sequence Number: 17301874
• Product Code: LKK
• UDI-Device Identifier: 10886704043621
• UDI-Public: 10886704043621
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2016
• 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): 06/07/2021

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: AP03000UL
• 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: 06/07/2021
• 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: 77 YR
• Patient Weight: 74