MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8578
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 8637-40, serial#: (b)(4), implanted: (b)(6) 2014, product type: pump.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On 2020-oct-23, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving dilaudid (10 mg/ml) via an implantable pump for non-malignant pain and complex regional pain syndrome type 1.It was reported that during a procedure, the hcp was unable to aspirate the catheter and chose to replace the pump segment.No external factors known.The issue was resolved with replacement of the pump segment of the catheter.The patient's status was alive, no injury.
Additional Manufacturer Narrative
Continuation of d11: product id: 8637-40, serial# (b)(6), implanted: (b)(6) 2014, explanted: (b)(6) 2020, product type: pump.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a company representative who reported that the inability to aspirate the catheter occurred during a routine pump replacement procedure.
Additional Manufacturer Narrative
H3: analysis of the implantable intrathecal catheters (s/n: (b)(6) found no significant anomalies which affected infusion.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: NA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10742949
• Report Number: 3004209178-2020-18778
• Device Sequence Number: 16441916
• Product Code: LKK
• UDI-Device Identifier: 00643169100879
• UDI-Public: 00643169100879
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2015
• Device Model Number: 8578
• Device Catalogue Number: 8578
• Device Lot Number: H913875005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 01/29/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 10/30/2020; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR