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

Model Number	AP03000L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 arrow or codman.If further information is obtained, it will be filed in a supplemental report.Infection is a known complication as listed on the labeling of the arrow/codman 3000 device.At this time, it is unknown the exact treatment course for the patient; however, the low flow model (which was used by this patient) is indicated and typically prescribed for intrathecal delivery of medication to treat either chronic pain or spasticity.It is unknown the exact relationship between the infection and pump.The date of the occurrence of the infection is currently unknown.The manufacture and sterilization of the model 3000 is no longer located where this particular device was produced.There is currently no trend to suggest a field nonconformance with the model 3000.
Event or Problem Description
Device tracking card was returned, stated pump "got infected, removed.".
Additional Manufacturer Narrative
Updated information provided based on returned information from physician.Exact explant date is unknown and estimated based off of provided information.Since the infection occured approximately 20 years after implant, this is suggestive that there was no sterility issue with the device as manufactured.Infection is a known adverse event as listed on the labeling of the codman 3000 pump.The manufacture and sterilization of the model 3000 is no longer located where this particular device was manufactured.There is currently no trend to suggest a field nonconformance with the model 3000.
Event or Problem Description
Explanting physician provided additional information after initial report: patient was seen for surgical site inspection after noticing infection.Patient had been taking morphine, 35 mg/ml, intrathecally via the pump.Pump was surgically removed and patient was placed on oral medication for pain management.No further information was provided.

• Brand Name: ARROW 3000
• Common Device Name: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11872971
• Report Number: 3015537318-2021-00017
• Device Sequence Number: 3215903
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2020
• 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): 06/14/2021

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: AP03000L
• Device Catalogue Number: AP03000L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/14/2021
• 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: 68 YR
• Patient Weight: 78