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

Model Number	ARROW 3000
Medical Device Problem Codes	Material Frayed (1262); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	10/28/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, it is unknown if the adverse event pertains to the device or to the drug regimen, or if there is an alleged malfunction of the device that has contributed to the adverse event.In order to obtain additional information regarding the adverse event, intera contacted the refill physician's office via direct signature required letter.No additional information has been received at the time of this report in order to clarify the complaint; if further information is received, it will be filed in a supplemental report.
Event or Problem Description
Patient responded to device tracking card mailing.Patient wrote "no more" in section for current refill physician, and also wrote "it was killing me.".
Additional Manufacturer Narrative
Codman (arrow) pumps are not labeled to be implanted with a dacron pouch but was present during explant, so it appears that the use of this pouch is off-label.Blank entries on the mdr form represent unknown information.
Event or Problem Description
Explanting physician's office provided operating report for when the device was previously explanted.Patient diagnoses was postlaminectomy syndrome, lumbar spine, with severe intractable pain.Operating report stated that the arrow (now codman) pump was implanted with a dacron pouch.The dacron pouch, the pump, and catheter were removed and replaced with a medtronic pump.The catheter appeared to have been frayed and was cut with scissors and tied off.The catheter that was frayed was not identified as a codman catheter or other catheter in the operative report.The operative report did not identify any other visible mechanical damage to the device.The explanting physician's office stated that patient is no longer seen at that practice.

• 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: 11880482
• Report Number: 3015537318-2021-00019
• Device Sequence Number: 16497262
• Product Code: LKK
• UDI-Device Identifier: 10886704043614
• UDI-Public: 10886704043614
• 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: 2001
• Device Explanted Year: 2009
• 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): 07/12/2021

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: ARROW 3000
• Device Catalogue Number: AP03000M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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