MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODOMAN 3000; IMPLANTED DRUG DELIVERY PUMP

Model Number	CODMAN 3000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the fact that the device was disposed of at the time of explant, a full investigation likely cannot be completed.The implanting physician is no longer in practice (is currently incarcerated for felony convictions) and thus cannot be reached for further investigation.Therefore, investigation details pertaining to the surgical placement of the device are unavailable.The explant physician is currently in practice and has been contacted via direct-signature required letter.No information has been received as of the date of this report.If additional information is received upon further contacts with the explant physician, 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, 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 card mailing.Patient wrote: "pump has not been refilled in more than 5 years - was not placed correctly." patient stated that pump was explanted in (b)(6) 2019, exact date was not provided.

• Brand Name: CODOMAN 3000
• Common Device Name: IMPLANTED DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11870425
• Report Number: 3015537318-2021-00015
• Device Sequence Number: 3215902
• 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: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: CODMAN 3000
• 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
• Initial Report FDA Received Date: 05/24/2021
• 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