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

Model Number	3000-L
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Numbness (2415); Balance Problems (4401)
Type of Reportable Event	Serious Injury
Event or Problem Description
Citation: gui m., sehgal n.2023.Symptomatic intrathecal catheter tip granuloma formation with ultralow-dose and low-concentration morphine infusion: a case report and review of literature.Neuromodulation jun 27 2023; 1-7.Doi:https://doi.Org/10.1016/j.It was reported that a 55-year-old male patient with l5-s1 fusion and chronic lumbosacral radiculopathy reported numbness and weakness in both lower limbs during routine pump refill visits.He had a non-programmable, constant-flow (0.5ml/d) codman®3000 pain pump implanted 5 years prior for pain management.The patient initially presented for chronic low back pain with multiple lumbar spine surgeries, including recent l5-s1anterior and posterior spinal fusion complicated by staphylococcus aureus surgical site infection.At the time of initial evaluation for pump implant, there were permanent but stable sensory motor deficits in the lower limbs on baseline neurologic examination.No complications were noted at the time of pump placement with catheter in subarachnoid space at t10.A codman®3000 pain pump with flexitip plus, 19-gauge, codman catheter (closed end, fenestrated, medical grade silicone impregnated with barium sulfate ) was implanted.Patient was started on it preservative-free morphine 240 mcg/d (480mcg/ml at a rate of 0.5ml/d) and was titrated up to 600 mcg/d (1200 mcg/ml at a rate of 0.5ml/d) over the course of three years for satisfactory pain control.He had discontinued oral and transdermal opioids and reported improved quality of life, pain relief,and function with it morphine.Two years after pump implantation, he underwent c5-7 anterior cervical discectomy and fusion.He presented with gradually worsening circumferential numbness from the level of the umbilicus distally and weakness in his legs, unsteady gait, falling because of his "legs giving out suddenly," and sharp shooting pain radiating to his legs on sneezing.He had reduced pain relief with it morphine.Aspirated drug volumes from the pump exceeded expected drug volumes during pump refills.He had paresthesia in the left flank and a sensory level at t10-11 with decreased pinprick and hyperreflexia in lower limbs on neurologic examination.A thoracics pinemagnetic resonance imaging (mri) with contrast revealed a leftextradural contrast enhancing mass at catheter tip at t9 vertebra level, with cord compression.He under went urgent t8-t11 thoracic laminectomy with granuloma resection and partial removal of the catheter.Histopathology revealed a fibrous, whitish-gray mass with densely mphoid infiltrate of primarily small cells admixed with scattered histiocytes.Microscopy and cultures were negative for bacterial, acid-fast bacilli, and fungal infection.Flow cytometry analysis was negative for lymphoma.Total time from initial pump implantation to discovery and subsequent granuloma removal was 49 months.Following surgical resection, the patient noted partial recovery of sensation and strength in his lower limbs with improvement in balance.He requested resuming it analgesia with pump for ongoing pain management and a new codman pump and catheter implanted (codman®3000 pain pump with flexitipplus 19-gauge, codman catheter), with the catheter tip positioned at t11.Since the implant, he has required one dose adjustment, and he is currently receiving 750 mcg/d (1500mcg/ml) of morphine.
Additional Manufacturer Narrative
Intera oncology acquired pma p890055 from codman & shurtleff/cerenovous in 2020.Intera oncology does not currently manufacture the 3000 low flow infusion pump.Intera oncology does not currently market devices for morphine or baclofen infusion.Blank information in the mdr form represents unknown information.If further information is received, 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: 17463453
• Report Number: 3015537318-2023-00031
• Device Sequence Number: 2698867
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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: 3000-L
• Device Catalogue Number: 3000-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/04/2023
• 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: 55 YR
• Patient Sex: Male