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

Model Number 8637-20

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

Information was received from the company representative (rep) regarding a patient who was receiving clonidine (9 mcg/day/ 25 mcg/ml) dilaudid (hydromorphone) (9 mcg/day/ 25 mcg/ml) via an implantable pump.The indication for use was not provided.It was reported that the company representative (rep) was in operation room (or) and the pump had been replaced with pump and catheter connected at the time of call.The rep stated that at attempt to aspirate the catheter they did not get back a volume that made the doctor feel as though the catheter was completely cleared.The rep stated he was able to get back a small volume (exact amount unknown).The rep wanted to know how to proceed with the prime and explained basics of prime that if there was still drug at the tip of the catheter and any sort of prime was done that it could potentially go intrathecal and bolus the patient.The catheter volume was 0.15 ml and caller stated they may consider doing a prime of just the internal pump tubing volume as the healthcare provider (hcp) stated he wanted to do the "minimum" prime possible.The technician explained it was hard to know what minimum means but to present both the full system prime and internal pump tubing volume prime (knowing there is still the chance to bolus) to the hcp to have them decide.The patient was getting dilaudid and clonidine at 25 mg/ml and dose per day of 9 mg.The tech (b)(6) 2022 e1(rep): additional information received from the company representative (rep) regarding, ¿the doctor told me he would keep the pt longer than normal for observation.Dr.Edwin colon, and pt anna florer.¿.

Manufacturer Narrative

Concomiatn medical devices: product id: 8709sc, serial/ lot# (b)(4).Implanted: (b)(6) 2009, product type catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 13-jan-2011, udi#: (b)(4).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 8709sc lot# serial# (b)(6).Implanted: (b)(6) 2009.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

2022-11-17 e1(rep): additional information received from the company representative (rep) regarding the patient and healthcare provider information.The cause of the healthcare provider (hcp) not being able to aspirate the catheter was unknown.The hcp performed a dye study with the knowledge of it possibly blousing the patient.The hcp reported that the catheter was patent and intact.The hcp was able to aspirate due the catheter being intact and patent.The hcp was able to aspirate 0.5 ml.

• 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: 15757163
• MDR Text Key: 307615899
• Report Number: 3004209178-2022-14684
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634094
• UDI-Public: 00763000634094
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/22/2022
• Date Device Manufactured: 10/21/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female