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

Model Number	AP03000L
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If further information is received at a later date, a supplemental report will be filed.
Event or Problem Description
A report from a healthcare provider was received by intera describing a patient with increased pain.The patient has a codman 3000 pump with a low flow rate of 0.5 ml/day, which was implanted on (b)(6) 2010.It was reported that the pump has had a consistently calculated flow rate of 0.3-0.42 ml/day for about 7 years; residual volume would be between 5-7 ml per refill.The last refill was performed on (b)(6) 2022 with a residual volume of 17 ml returned (calculated flow rate of 0.2 ml/day).Patient did not complain of increased pain on (b)(6) 2022 but reported increased pain during a phone check in with the healthcare provider on (b)(6) 2022.It was reported that the patient has a history of granuloma formation at the tip of the catheter.The healthcare provider planned for a dye study in order ot assess the functionality of the catheter, but it had not yet been performed at the time of this report.
Event or Problem Description
The healthcare provider planned for a dye study in order to assess the functionality of the catheter and attempted the study on (b)(6) 2022.The healthcare provider attempted to aspirate the bolus pathway to determine the patency of the catheter and were unable to aspirate, indicating a problem with the catheter (i.E.Catheter kink, granuloma, etc).The problem was not further interrogated, and the dye study was not conducted.The intrathecal catheter was not reported.The clinic reported they plan to replace the pump and catheter system as the codman 3000 is no longer manufactured for intrathecal use.
Additional Manufacturer Narrative
The codman 3000 was discontinued for intrathecal applications in 2018.The device remains implanted at the time of this report.The codman 3000 was not indicated for use with hydromorphone, clonidine, or bupivacaine.Blank information in the mdr form represents unknown information at the time of this report.If further information is received at a later date, a supplemental report will be filed.

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• Manufacturer (Section G): INTERA ONCOLOGY; 65 william street; suite 200; wellesley MA 02481
• Manufacturer Contact: sarah lapp ; 65 william street; suite 200; wellesley, MA 02481 ; 7814895724
• MDR Report Key: 14242325
• Report Number: 3015537318-2022-00008
• Device Sequence Number: 12015742
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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: AP03000L
• Device Catalogue Number: AP03000L
• Device Lot Number: 412484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male