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

Model Number	ARROW 3000
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/01/2002
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of call, the device remained implanted.If additional information is received, a supplemental report will be filed.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, the suitability of a drug delivery pump vs other treatments (such as spinal cord stimulation), catheter migration, 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 clinical call line - stated that pump was not providing pain relief and not working for years.Patient inquired if she needed to have it removed or not.
Additional Manufacturer Narrative
No medical interventions pertaining to the pump will be performed and the device is not expected to be explanted; therefore, the alleged device malfunction and root cause cannot be confirmed.Blank information in the report form represents unknown information.
Event or Problem Description
Question template pertaining to the alleged product problem was sent to the patient's health care provider, and answers were obtained over the phone.Patient stated to health care provider that pump stopped working one year after implant, but patient is not a candidate for surgery as decided upon by patient's surgeon.No further interventions pertaining to the pump will be performed.

• Brand Name: ARROW 3000
• Common Device Name: IMPLANTABLE DRUG INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11838680
• Report Number: 3015537318-2021-00009
• Device Sequence Number: 3426327
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• 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): 06/24/2021

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: ARROW 3000
• Device Catalogue Number: AP03000L
• 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: 06/24/2021
• 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: 53 YR