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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems Fatigue (1849); High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Anxiety (2328); Malaise (2359); Shaking/Tremors (2515); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8784, serial#: (b)(4).Implanted: (b)(6) 2020, explanted: (b)(6) 2022.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 04-nov-2022, 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 Description

Information was received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) regarding a patient receiving fentanyl, hydromorphone, and bupivacaine via an implantable pump.It was reported on (b)(6) 2021 the patient reported they have been "miserable" due to pain.The patient requested oral medication which was denied.The device was reprogrammed where the fentanyl and boluses were increased.On (b)(6) 2021 a catheter dye study was performed due to increased pain.The catheter dye study was normal.On (b)(6) 2021 the hcp increased the bupivacaine to 4.5 mg, decreased the fentanyl to 900 mcg, and decreased the hydromorphone to 1.5 mg.No other changes were made.On (b)(6) 2021 the patient reported their pain was a 7/10.The device was reprogrammed where the bupivacaine was increased.On (b)(6) 2021 the patient reported improvement in pain and reported pain levels were at 1-2/10.The patient started that when she laid down they felt their boluses, but when they were sitting or standing they do not.On (b)(6) 2022 the patient requested oral medication for breakthrough pain.The patient reported their pain was 6/10.Percocet was prescribed.The device was reprogrammed where the bupivacaine was increased.On (b)(6) 2022 the patient reported significant pain and reported not feeling well and felt as if they were having withdrawal.The patient's symptoms included shakiness, high blood pressure, fatigue, nausea, poor appetite, jittery, and nervous.A catheter dye study was ordered and scheduled.On (b)(6) 2022 a catheter dye study was performed which revealed a sluggish and kinked catheter.During the dye study, the hcp was able to aspirate and push dye through the system, but noted the catheter was sluggish.The pump system was intact and functional.The patient has reported since (b)(6) 2020, the patient intermittently went through withdrawal.The last three refills since (b)(6) 2021.Were checked and the clinic pulled out exactly what they expected.A catheter revision was scheduled.There were no factors that may have led or contributed to the issue.On (b)(6) 2022 the hcp assumed that the patient has been experiencing a ¿dynamic kinking of the ascenda catheter¿ however when they opened up the spine, the patient's spinal segment was patent and the hcp was getting free flowing csf (cerebral spinal fluid) when they cut the catheter intentionally at the site of the collette.The hcp then added a new collette from an 8785 and opened up the pump pocket.This was where it was discovered that the patient had a ¿fraying¿ at the pump pocket portion of the catheter.The pump catheter was explanted/replaced on (b)(6) 2022.The hcp added a new 8784 and was able to aspirate from the cap (catheter access port)easily and 2 cc¿s.Surgery resolved the issue/the outcome of the event resolved without sequelae on (b)(6) 2022, and the patient felt their bolus.The patient's status was alive- no injury.The device diagnosis was catheter kink.The clinical diagnosis was it (intrathecal) medical withdrawal/withdrawal symptoms.It was noted that while the catheter was intentionally cut, the hcp wanted to program a bolus from the pump to see if they could see drug dripping out of the pump segment while it was disconnected from the spinal segment.The hcp had the rep program a large bolus which was canceled when they observed drug drip out of the pump segment.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.Medications included calcium, clindamycin hcl 300 mg capsule, hibiclens 4% topical liquid, hydrochlorothiazide 25 mg tablet, lasix 40 mg tablet, multivitamin, mupirocin 2% topical ointment, oxycodone 10 mg tablet, percocet 5 mg-325 mg tablet, tizanidine 4 mg capsule, vitamin b complex tablet, vitamin d3 5,000 unit tablet, and zolpidem 5 mg tablet.Allergies included amoxicillin trihydrate (rash/rash on hands), gabapentin (edema), ibuprofen (gi, heartburn), ketorolac (gi, heartburn), tromethamine, lisinopril, methylprednisolone, naproxen sodium (gi, heartburn), and potassium clavulanate (rash).The diagnosis was post laminectomy syndrome, not elsewhere classified.

Manufacturer Narrative

Continuation of d10: product id 8782 serial# (b)(6) product type catheter product id 8784 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2022 product type catheter h3: the 8784 catheter was returned and analysis identified there was damage to the transition tubing and that the collet was not fully locked into place.The 8782 catheter was returned and no significant anomalies were found.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.

Manufacturer Narrative

Continuation of d10: product id 8782 serial# (b)(6): product type catheter product id 8782 serial# unknown: product type catheter product id 8784 serial# (b)(6) implanted: (b)(6) 2020 explanted: 2022-02-08 product type catheter h3: the 8782 (unknown serial #) catheter was returned and analysis identified a kink.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: SYNCHROMED II
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13580946
• MDR Text Key: 288180679
• Report Number: 3004209178-2022-02377
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 05/06/2022; 03/16/2023
• Supplement Dates FDA Received: 05/11/2022; 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10....".
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 103 KG