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); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  Injury  

Event Description

It was reported the patient was admitted to hospital due to possible pocket fill.Nurse gave patient a single bolus of 60 mcg fentanyl.The patient began to fall asleep and was un-arousable.Narcan was given twice nasally and intramuscularly.Blood and unknown particles exited the patient's nose after narcan.Ems called and rescue breathing was performed.Patient was admitted to hospital.The nurse visited patient at hospital to refill pump with saline and set to minimal flow.Pump emptied, the interrogated amount was 39.8 and 39.6 ccs were pulled out.On (b)(6) 2022, the patient denied taking any illegal substances and they did not use boluses or oral medications.A catheter access port (cap) contrast study was performed and failed.The device diagnosis was catheter dislodgement.Catheter revision required.It was indicated the event was possibly related to the device or therapy.The event was ongoing.Additional information was received from the clinical study team indicated that a pocket fill did not occur.The nurse extracted 39.6ml from pump which was the expected amount, ruling out a pocket fill.The cause of the patient's drowsiness was opioid overdose.

Manufacturer Narrative

Concomitant products: product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: 12-nov-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider via a clinical study indicated that the patient experienced life-threatening illness or injury.

Manufacturer Narrative

Continuation of d10: product id 8596sc serial# (b)(6) implanted: (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 8596sc lot# serial# (b)(6) implanted: (b)(6) 2021 product type catheter product id 8598a lot# serial# (b)(6) product type catheter h3: the 8596sc catheter was returned and no anomalies were noted on microscopic inspection, the catheter was patent, and passed pressure leak testing.The 8598a was returned and visual inspection identified a break in the 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.

• 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: 13937474
• MDR Text Key: 288091149
• Report Number: 3004209178-2022-03898
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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
• Patient Outcome(s): Life Threatening; Other; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female