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

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_prog, product type programmer, physician nformation references the main component of the system.Other relevant device(s) are: 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

Information was received from healthcare professional (hcp) regarding a patient receiving bupivacaine (4 mg/ml/1.1515 mg/day)/ hydromorphone (4 mg/ml/1.1515 mg/day)/ baclofen (240 mcg/ml/concentration dosage unknown) via an implantable pump.The indication for use was non-malignant pain.It was reported that the pump was refilled (b)(6) 2022 and it was found that the nurse made a programming error and entered 40 milli liter (ml) as a reservoir volume and actually only filled the pump with 19 ml.The healthcare provider (hcp) stated last week the patient was seen because she had a loss of therapy and after doing some investigation found this programming error.Flow rate 0.287ml/day 19ml= 66.2 days of delivery from (b)(6) 2022.The hcp stated yesterday ((b)(6) 2022), he refilled the pump with pfns and programmed the pump to min rate mode and today they are refilling with the same drug and concentration.It was discussed 0.0006 infused since (b)(6) 2022.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_prog lot# serial# implanted: explanted: product type programmer, physician product id neu_unknown_prog lot# 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.

Event Description

Information was received from healthcare professional (hcp) regarding a patient receiving bupivacaine (4 mg/ml/1.1515 mg/day)/ hydromorphone (4 mg/ml/1.1515 mg/day)/ baclofen (240 mcg/ml/concentration dosage unknown) via an implantable pump.The indication for use was non-malignant pain.It was reported that the pump was refilled (b)(6) 2022 and it was found that the nurse made a programming error and entered 40 milli liter (ml) as a reservoir volume and actually only filled the pump with 19 ml.The healthcare provider (hcp) stated last week the patient was seen because she had a loss of therapy and after doing some investigation found this programming error.Flow rate 0.287ml/day 19ml= 66.2 days of delivery from (b)(6) 2022.The hcp stated yesterday ((b)(6) 2022), he refilled the pump with pfns and programmed the pump to min rate mode and today they are refilling with the same drug and concentration.It was discussed 0.0006 infused since (b)(6) 2022.

Manufacturer Narrative

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

Information was received from healthcare professional (hcp) regarding a patient receiving bupivacaine (4 mg/ml/1.1515 mg/day)/ hydromorphone (4 mg/ml/1.1515 mg/day)/ baclofen (240 mcg/ml/concentration dosage unknown) via an implantable pump.The indication for use was non-malignant pain.It was reported that the pump was refilled (b)(6) 2022 and it was found that the nurse made a programming error and entered 40 milli liter (ml) as a reservoir volume and actually only filled the pump with 19 ml.The healthcare provider (hcp) stated last week the patient was seen because she had a loss of therapy and after doing some investigation found this programming error.Flow rate 0.287ml/day 19ml= 66.2 days of delivery from (b)(6) 2022.The hcp stated yesterday ((b)(6) 2022.He refilled the pump with pfns and programmed the pump to min rate mode and today they are refilling with the same drug and concentration.It was discussed 0.0006 infused since (b)(6) 2022.

Manufacturer Narrative

Continuation of d10: product id: neu_unknown_prog, serial# unknown, product type: programmer, physician.Product id: neu_unknown_prog, serial# unknown, 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

Information was received from healthcare professional (hcp) regarding a patient receiving bupivacaine (4 mg/ml/1.1515 mg/day)/ hydromorphone (4 mg/ml/1.1515 mg/day)/ baclofen (240 mcg/ml/concentration dosage unknown) via an implantable pump.The indication for use was non-malignant pain.It was reported that the pump was refilled on 2022-06-03 and it was found that the nurse made a programming error and entered 40 milli liter (ml) as a reservoir volume and actually only filled the pump with 19 ml.The healthcare provider (hcp) stated last week the patient was seen because she had a loss of therapy and after doing some investigation found this programming error.Flow rate 0.287ml/day 19ml= 66.2 days of delivery from 2022-06-03.The hcp stated yesterday ((b)(6) 2022 ), he refilled the pump with pfns and programmed the pump to min rate mode and today they are refilling with the same drug and concentration.It was discussed 0.0006 infused since (b)(6) 2022.

• 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: 15327725
• MDR Text Key: 305493272
• Report Number: 3004209178-2022-11138
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• 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: 09/27/2022
• Date Device Manufactured: 08/13/2019
• 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 Age: 59 YR
• Patient Sex: Female