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

Model Number 8637-40

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Pain (1994); Vomiting (2144); Loss of consciousness (2418); Diaphoresis (2452); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Information was received from a patient who was receiving dilaudid (hydromorphone) (6 mg/ml at 3.2443 mg/day) and bupivacaine (12 mg/ml at 6.489 mg/day) via an implantable pump for unknown indications for use.It was reported that twice the pump has alarmed.The patient stated that the first time there was a tiny bit of medication in the catheter and this second time they gave appointment date and changed without patient knowing.The patient stated that one (b)(6) 2023 the patient was due to alarm and was at their appointment but they told patient they changed date which the patient did not know.The patient stated that the pump did start alarming (b)(6) 2023 with long beeps and now going to a critical alarm which goes off every 10 minutes which started yesterday ((b)(6) 2023) and before was every few hours.The patient stated that they set up an another appointment on (b)(6) 2023 and wondered if the patient can make it to the 10th.The patient noted that their healthcare provider was not aware of the alarm as the healthcare provider was on vacation.The patient was redirected to their healthcare provider to further address the issue.During call the patient provided the print out of an old report and stated since the print out there has been an increase of medication of 17% because the patient was still hurting and was trying to use oral medication but the increase avoided the medications.Patient services reviewed to seek medical attention if necessary.The patient stated having oral morphine but does not like to take the medication unless they have to.The patient stated hurting so bad at appointment and could not wait much longer at the appointment.Additional information was received from a healthcare provider (hcp) via a manufacturer representative.It was reported the pump went empty sometime last week and the patient presented to the hospital with withdrawal symptoms.The patient presented to the hcp office for a refill on (b)(6) 2023 and the hcp programmed a priming bolus of the pump and catheter at refill.The patient was then found unresponsive, diaphoretic, and vomiting, in their car at hcp office.An environmental/ external factor that may have contributed to the issue was the physician programming, per hcp the patient may have also been hypoglycemic.As a diagnostic and intervention the physician gave the patient narcan, sugar, called emergency medical services (ems) and the patient was transported to the hospital.The issue was resolved at the time of the report, and the patient status was alive- no injury.The patients weight and medical history were asked but were unknown.

Manufacturer Narrative

Concomitant medical products: product id : neu_unknown_prog , serial# : unknown.Product type: programmer, physician.Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown.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 the healthcare provider (hcp) via company representative (rep) indicated the serial/lot number of the hcp's programmer was unknown due to the rep being out of the field and unable to retrieve this information at this time.It was confirmed the hcp had programmed a priming bolus of the pump and catheter at the refill which would be a procedure issue since a priming bolus was not needed.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_prog lot# serial# unknown implanted: explanted: product type programmer, physician.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 the healthcare provider (hcp) via company representative (rep) indicated the hcp programmed a priming bolus of the pump and catheter at refill while he did not need to program a priming bolus.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_prog, serial# implanted: explanted: product type programmer, physician.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: 16165136
• MDR Text Key: 307468650
• Report Number: 3004209178-2023-00634
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634100
• UDI-Public: 00763000634100
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2023
• Date Device Manufactured: 09/01/2022
• 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): Other
• Patient Age: 67 YR
• Patient Sex: Female