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

Model Number	CODMAN 3000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Inadequate Pain Relief (2388)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Blank fields in the mdr form represent unknown information.
Event or Problem 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
• Common Device Name: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11899087
• Report Number: 3015537318-2021-00022
• Device Sequence Number: 19938492
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• 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: 2013
• Device Explanted Year: 2021
• 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): 07/13/2021

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: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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