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

Model Number	ARROW 3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant physician was contacted via required-signature delivery to obtain more information about the complaint.No response to date has been received as of the date of this report.If additional information is received, a supplemental report will be filed.Based on the age of the complaint and the fact that both devices were disposed of at the time of explant, a full investigation may not be completed.The explant date of the second pump was not provided.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, pump flow rate, the suitability of a drug delivery pump vs other treatments (such as spinal cord stimulation), catheter migration or malfunction, 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 the clinical call line.Stated he had "two pumps that did not give any pain relief, could not deliver morphine.".
Event or Problem Description
The patient's healthcare provider was contacted to obtain additional information pertaining to the adverse event.The healthcare provider suggested that the adverse event was cellulitis, but was unable to povide further details and did not specify which pump was associated with the infection.The patient was prescribed morphine for pain relief.The patient's medical records were unavailable for further confirmation of the adverse event.Explant date was not provided.
Additional Manufacturer Narrative
Patient records were unavailbale due to the age of the complaint and subsquent records.The exact nature of the adverse event is unknown.

• 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: 11838734
• Report Number: 3015537318-2021-00013
• Device Sequence Number: 14611123
• Product Code: LKK
• UDI-Device Identifier: 10886704043614
• UDI-Public: 10886704043614
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• 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): 07/06/2021

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: AP03000M
• 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: 07/06/2021
• 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: 55 YR
• Patient Weight: 68