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

Model Number AP03000L

Device Problem Use of Device Problem (1670)

Patient Problems Nausea (1970); Vomiting (2144); Convulsion/Seizure (4406)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

If further information is later recieved received, a supplemental report will be filed.

Event Description

A call to the clinical call line from a health care provider was received on (b)(6) 2021 regarding a patient who was admitted to a hospital with suspected morphine withdrawal.The patient has a codman 3000 pump, low flow, which is being used to deliver morphine to treat chronic pain.Patient symptoms were reported to be convulsions, nausea and vomiting.The patient was treated with iv morphine to treat withdrawal symptoms.It was initially reported that the patient's prior refill was (b)(6) 2021 and the next refill was scheduled for (b)(6) 2021.The pump is a 30ml pump with a flow rate of 0.5ml/day.Intera clinical informed the health care provider that the pump is never to be allowed to go below 2 ml in the reservoir, so should be refilled no later than at 56-58 days from the last refill (per the codman 3000 ifu).The date of adverse event ((b)(6) 2021) was 63 days from the last refill, so the pump is most likely empty and the patient went into in morphine withdrawal.Further discussion with the health care provider's office on nov 9, 2021 later clarified that the patient was also scheduled for a pump refill on (b)(6) 2021, which would have been within the refill interval; however, patient was administered a sacroiliac injection instead of a pump refill.Health care provided stated this was a scheduling error by the healthcare provider's office.Patient had pump refilled in the hospital on (b)(6) 2021 and discharged at a later date.Exact date of discharge was not reported.The patient later called the healthcare provider's office on (b)(6) 2021 to report that she felt cold and clammy and could hear heartbeat.The healthcare provider instructed her to go to the hospital for a pneumonia diagnosis as he felt these symptoms were not symptoms of morphine withdrawal.It is unknown if the patient actually went to the hospital at this time.The patient returned to the healthcare provider on (b)(6) 2021 to report that she still had morphine withdrawal symptoms that would "come and go." the health care provider prescribed tramadol by mouth for symptoms, and the patient continues to take tizanidine for muscle contractions.No device malfunction was reported or alleged.Pump explant is not currently planned at the time of this report.

• Brand Name: CODMAN 3000
• Type of Device: 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: 12860770
• MDR Text Key: 286061508
• Report Number: 3015537318-2021-00029
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AP03000L
• Device Catalogue Number: AP03000L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TIZANIDINE; TRAMADOL
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White