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

Model Number CODMAN 3000

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Inadequate Pain Relief (2388)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Exact date of the adverse event is unknown and is estimated to be in 2014.The description of the complaint from the patient suggests either a catheter or pump migration.Migration is a known complication for intrathecal pump therapy as per the codman 3000 labeling.The implant physician for this patient is no longer in practice (incarcerated for felony crimes), so further investigation to implant technique cannot be obtained.Intera has requested information from the explanting physician to confirm the adverse event.At this time, it is not know if the device has explanted, although an explant is planned.If further infomration is received to confirm the adverse event, it will be added as a supplemental report.

Event Description

Patient returned device tracking card, patient had written "pump hasn't worked in over 6 years, trying to find a doctor to remove due to stomach pain because it has moved." patient later returned a call to the clinical call line and stated she has found a doctor that will remove the pump.He did a "scan" of the pump which has migrated to just below her belly button and is stable there but painful.The "scan" showed where the pump is and the catheter is coiled up under the pump.The pump started migrating about 6 months after implant.The drugs in the pump were 'dilaudid, baclofen and something else.' she stated she never got pain relief from the pump.

Manufacturer Narrative

Blank fields in the mdr form represent unknown information.

Event Description

Device was explanted and explanting physician confirmed that the catheter had migrated and was coiled under the pump, and thus was unable to deliver therapy.Exact explant date was not provided but was performed in 2021.

• Brand Name: CODMAN 3000
• Type of Device: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11899087
• MDR Text Key: 253464950
• Report Number: 3015537318-2021-00022
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (y/n): Y
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CODMAN 3000
• Device Catalogue Number: AP03000L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention