MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC MODEL 3000 - 30ML VOLUME, LOW; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Catalog Number	AP03000L
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This initial mdr will be the only report submitted for mfr report #1226348-2018-00655.Additional patient, event, and initial reporter information was requested, but has not yet been provided.The product will not be returned for analysis and additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a patient implanted with a codman 3000 (ap03000l/13116) presented at the er in an altered mental state.The nurse called for assistance on how to slow down the pump flow.It was unknown when the patient's last refill was; however, the next refill was scheduled for (b)(6) 2018.The pump had morphine and bupivacaine in it.Reportedly, the patient is also on several oral medication, including: hydrocodone, dilaudid, and flexeril.
Additional Manufacturer Narrative
Product complaint # (b)(4).This final mdr will be the only report submitted for mfr report #1226348-2018-00655.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MODEL 3000 - 30ML VOLUME, LOW
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7712251
• Report Number: 1226348-2018-00655
• Device Sequence Number: 805410
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): N
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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 Catalogue Number: AP03000L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/27/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention