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

Model Number	8598A
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 8637-40, serial#: (b)(4), implanted: (b)(6) 2020, product type: pump.Other relevant device(s) are: product id: 8637-40, serial/lot #: (b)(4), ubd: 28-dec-2021, udi#: (b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) and a consumer via a clinical study and a manufacturer representative (rep) regarding a patient receiving morphine 20 mg for a total dose of 5.49908 mg/day and bupivacaine 7.3 mg for a total dose of 2.00716 mg/day via an implantable pump.It was reported the patient reported increased pain over the past three months.On (b)(6) 2021 the patient had a catheter dye study (cds).The cds failed as they were unable to aspirate the catheter.Factors that may have led or contributed to the event included a possible fall.The surgical procedure was revision/replacement of intrathecal catheter and possible revision of pump pocket site.The spinal catheter was explanted/replaced on (b)(6) 2021.At time of surgery it was noted the spinal catheter was occluded and they were unable to aspirate.The outcome of the event resolved without sequelae on (b)(6) 2021.The patient's status at time of report was alive- no injury.The device diagnosis was pump unable to enter/withdraw from catheter access port and catheter occlusion.The pump was in the left upper buttock and the catheter tip was t7.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was (b)(6) 2021.Medications included ambien 5 mg tablet, atorvastatin 10 mg tablet, breoelipta 200 mcg-25 mcg/dose powder for inhalation, cephalexin 500 mg capsule, diphenhydramine 25 mg tablet, eliquis 5 mg tablet, hibiclens 4% topical liquid, labetalol 200 mg tablet, lamotrigine 25 mg tablet, levothyroxine 125 mcg tablet, montelukast 10 mg tablet, mupirocin 2% topical ointment, narcan 4mg/actuation nasal spray, nasonex 50 mcg/actuation spray, nifedipine er 90mg tablet, oxycodone 10 mg tablet, senexon-s 8.6 mg-50mg tablet, and ventolin hfa 90 mcg actuation aerosol inhaler.Allergies include ace inhibitors, clindamycin hcl, and contrast dye.No further complications were reported/anticipated.
Additional Manufacturer Narrative
The catheter was returned, and analysis found a dried drug, blood, or foreign material occlusion of the catheter body.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.

• Brand Name: NA
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11859870
• Report Number: 3004209178-2021-08072
• Device Sequence Number: 14618348
• Product Code: LKK
• UDI-Device Identifier: 00643169887657
• UDI-Public: 00643169887657
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 08/20/2022
• Device Model Number: 8598A
• Device Catalogue Number: 8598A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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
• Patient Age: 59 YR
• Patient Weight: 112