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

Model Number 8637-20

Device Problems Filling Problem (1233); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_refillkit_acc, serial#: unknown, product type: accessory.Other relevant device(s) are: product id: neu_refillkit_acc, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) regarding a patient receiving morphine (10 mg/ml at 1.279 mg/day) via an implantable infusion pump.It was reported that the hcp was able to get all of the drug out of the patient's pump but was then only able to refill 12 cc.The caller stated that she used two refill kits and that the first kit had a leak in the tubing ( saw air in the tubing).The hcp was comfortable just refilling to 12 cc and waiting 30 minutes to call to see if there were any symptoms (caller reported there wasn't any) and agreed to call back at next the refill (couple months) to do troubleshooting if the locked valve is still activated.No further complications have been reported.

Event Description

Contact stated they did not know/remember the serial number/lot number of the refill kit.The kit was discarded.Contact noted that the kit had green tubing.They noted this because they have never had problems with the white tubing refill kits, only the green tubing refill kits.It was again reported that they refilled with what they could, and decided to leave it.Would be seeing the patient again at the beginning of october to refill and check.Caller called back reporting they brought the patient back for another refill yesterday and they were having the same exact issue as last time.She had another nurse with her just to confirm they were doing everything appropriately.They were able to pull back what they were expecting.They even tried holding back negative pressure to try to get any potential air bubbles or any old medication that might be in the pump and tried using a 20 ml syringe.The issue occurred when they were trying to inject into the pump.She wanted to try using saline to flush the pump first before filling it with medication.They took out the needle and tried to re-insert to make sure they were in the reservoir.When she tried to inject saline into the pump they saw a part of the refill kit leak (needle and tubing connection).At one point it was dripping like a faucet but only when she tried to inject.It was thought it might be a refill kit issue however they went through four total kits and the same issue happened with all four that they do not believe it was a kit issue (lot numbers asked unknown).It was confirmed with caller there were no hyperbaric or anything that might have caused a physical damage to pump.They reviewed considerations to do a lateral of the pump to make sure there's no damage or issues with bevels.A pump replacement was scheduled for next week and will send the pump back for analysis.Caller mentioned she spoke to her rep about this issue this morning.

Manufacturer Narrative

Continuation of d11: product id: neu_refillkit_acc; product type: accessory.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.

Manufacturer Narrative

Continuation of d11: product id: neu refillkit acc, serial# unknown, product type: accessory.H6: correction was made to this field.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 d11: product id neu_refillkit_acc, serial# unknown, product type: accessory.B2/h1: event is now reportable for serious injury as it was indicated that intervention was required.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

Contact stated they did not know/remember the serial number/lot number of the refill kit.The kit was discarded.Contact noted that the kit had green tubing.They noted this because they have never had problems with the white tubing refill kits, only the green tubing refill kits.It was again reported that they refilled with what they could, and decided to leave it.Would be seeing the patient again at the beginning of october to refill and check.Caller called back reporting they brought the patient back for another refill yesterday and they were having the same exact issue as last time.She had another nurse with her just to confirm they were doing everything appropriately.They were able to pull back what they were expecting.They even tried holding back negative pressure to try to get any potential air bubbles or any old medication that might be in the pump and tried using a 20 ml syringe.The issue occurred when they were trying to inject into the pump.She wanted to try using saline to flush the pump first before filling it with medication.They took out the needle and tried to re-insert to make sure they were in the reservoir.When she tried to inject saline into the pump they saw a part of the refill kit leak (needle and tubing connection).At one point it was dripping like a faucet but only when she tried to inject.It was thought it might be a refill kit issue however they went through four total kits and the same issue happened with all four that they do not believe it was a kit issue (lot numbers asked unknown).It was confirmed with caller there were no hyperbaric or anything that might have caused a physical damage to pump.They reviewed considerations to do a lateral of the pump to make sure there's no damage or issues with bevels.A pump replacement was scheduled for next week and will send the pump back for analysis.Caller mentioned she spoke to her rep about this issue this morning.

• 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
• MDR Report Key: 10459480
• MDR Text Key: 204580556
• Report Number: 3004209178-2020-14843
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2020

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: 11/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 09/23/2020; 10/27/2020
• Supplement Dates FDA Received: 10/21/2020; 10/22/2020; 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR