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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Failure to Disconnect (2541); Material Integrity Problem (2978)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Sleep Dysfunction (2517); Weight Changes (2607); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving fentanyl (unknown dose and concentration) via an implantable pump for unknown indications for use.It was reported that on (b)(6) 2021 the patient reported that the pump flips with movement.  it was reported the patient experiences pain when pump flips.  a pump pocket revision surgery was recommended.  the device was reprogrammed where the fentanyl was increased.  on (b)(6) 2021 oxycodone was prescribed for increased pain due to pump flipping and a tighter abdominal binder was given to the patient.The outcome was noted as ongoing.  the clinical and device issue was pump inversion.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.

Event Description

Additional information was received from the consumer via a company representative who reported that the patient presented on (b)(6) 2021 for their scheduled reprogramming and evaluation appointment where the patient complained of abdominal bilateral pain and lower back bilateral pain.The patient had been experiencing pain at their pocket site, nausea, vomiting, and weight loss.The patient would also awake frequently because of the pain.It was noted that the patient rated their pain at a 10/10 level.The patient stated that this was a more intense pain compared to the pain that they had experienced previously due to the pump flipping.It was indicated that the pump flipped every time they moved, and this began when they were doing yardwork and heard a loud snap.On (b)(6) 2021 a revision surgery occurred to secure the pump and prevent it from flipping.During surgery, the 8784 catheter was difficult to remove from the pump.A little piece of insulation was then seen hanging from the catheter as it was pulled off during troubleshooting.It looked like a 1/2 cm catheter tail off of the connector, so the catheter was replaced.There were no external/environmental/patient factors that may have led or contributed to the event.The issue was resolved at the time of the report.It was noted that the patient was receiving fentanyl (2000 mcg/ml at 599.2 mcg/day), bupivacaine (20 mg/ml at 5.992 mg/day), and hydromorphone (6 mg/ml at 1.7975 mg/day) via an implantable pump at the time of the event.The patient's medical history included intractable abdominal pain related to chronic pancreatitis.At the patient's previous appointment (unspecified date) their hydromorphone was increased by 0.5 mg simple continuous and they were programmed to receive 11 boluses per day, increased by one bolus.The patient was previously recommended for a lesi and cesi but the healthcare provider needed 4 appointments and update mri's before continuing with this.Medications included cephalexin 500 mg capsule, creon capsule, duloxetine hcl capsule, hibiclens 4% topical liquid, ibuprofen capsule, mupirocin 2% topical ointment, narcan 4 mg/actuation nasal spray, oxycodone 5 mg tablet, propranolol hcl capsule, and tylenol capsule.Allergies included acetaminophen, carbamazepine, fentanyl, hydrocodone, bitartrate, ketorolac, tromethamine, metoclopramide, tramadol, hcl, and tramadol hcl.Diagnosis description was lumbar region radiculopathy.The patient's status was alive - no injury.

Manufacturer Narrative

Continuation of d10: product id 8784 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2021 product type catheter.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: 8784 serial# (b)(6); implanted: (b)(6) 2021; explanted: (b)(6) 2021; product type: catheter.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 Description

Additional information received from a manufacture representative reported the patient was receiving fentanyl (2000 mcg/ml at 599.2 mcg/day), bupivacaine (20 mg/ml at 5.992 mg/day) and hydromorphone (6.0 mg/day at 1.7975 mg/day) via an implantable pump.

Manufacturer Narrative

H3: the catheter was returned, and analysis found damage to the connector that is consistent with difficulty detaching the catheter from the pump, and damage to the transition tubing.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: 12623752
• MDR Text Key: 276142553
• Report Number: 3004209178-2021-15278
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2022

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: 10/14/2022
• 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: 10/12/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 10/18/2021; 10/28/2021; 12/29/2021
• Supplement Dates FDA Received: 10/21/2021; 11/03/2021; 01/06/2022
• Date Device Manufactured: 04/19/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 57 KG