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

Model Number 8637-20

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

Patient Problems Fever (1858); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Muscular Rigidity (1968); Seroma (2069); Neck Pain (2433); Swelling/ Edema (4577)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781; serial#: (b)(4); explanted: (b)(6) 2022; product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 09-feb-2024, 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.

Event Description

Information was received from multiple sources (healthcare provider, foreign, distributor) regarding a patient who was receiving gabalon via an implantable pump for adrenoleukodystrophy (due to spasticity).The daily dose rate of gabalon was 244.9 mcg/day from (b)(6) 2022 and since discontinued.Past medical history and concomitant medications were indicated as being none.It was reported that the vicinity of the pump was expanded on (b)(6) 2022.There was an accumulation of serous fluid (infection) at the pump implantation site.The date of onset of the accumulation of serous fluid/infection was (b)(6) 2022.The patient also experienced headache and worsening spasticity with onset of (b)(6) 2022.On (b)(6) 2022, gabalon tablet administration was initiated regarding the above-mentioned symptoms.The above symptoms were alleviated.On (b)(6) 2022 the serous fluid around the pump was aspirated and the patient¿s symptoms had improved after all.On (b)(6) 2022 contrast radiography was attempted; however, there was also a possibility that liquid medicine could not be aspirated from the catheter and an adequate examination could not be performed.Serous fluid accumulated again on (b)(6) 2022.The catheter and pump were removed due to infection.It was suspected that the pump and catheter may not have been connected, but this was not identified.It was believed that there were are no problems with the pump or catheter itself due to loaner inspection and post-removal visual inspection.It was further reported that furthermore, the connection between the pump and the catheter was also not believed to be defective.The outcome of the serous fluid at the pump site / infection, was resolved as of (b)(6) 2022.The outcome of the headache and worsening spasticity was indicated as recovering.The causal relationship of the serous fluid accumulation / infection regarding drug and procedure was unrelated, and unknown if related to the catheter, pump, or procedure.The causal relationship of the headache to drug was related, and unknown if related to the catheter or pump.The causal relationship of the worsening spasticity to drug was related, and unknown if related to the catheter, pump, or procedure.The worsening spasticity was noted as not related to the programmer.

Manufacturer Narrative

Continuation of d10: product id 8781 lot# hg61yts17 serial# implanted: (b)(6) 2022, explanted: (b)(6) 2022, 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

Additional information was received from a foreign healthcare provider (hcp) via a distributor on 2022-aug-24.It was reported that the patient developed a fever, pain in their neck, and a headache at midnight on (b)(6) 2022.The patient visited the hospital and had a blood test performed.Inflammation findings were observed.Infection was suspected in the abdomen.The patient's sutures were removed on (b)(6) 2022 and the patient was discharged from the hospital after the pump removal.As of (b)(6) 2022, the event outcome was considered resolved.

Event Description

Additional information was received.It was indicated the hcp checked the catheter after removal, but no malfunctions were observed, so the cause of the issues was unknown.The pump and catheter were discarded.

Manufacturer Narrative

Continuation of d10: product id 8781, lot# hg61yts17, implanted: (b)(6) 2022, explanted: (b)(6) 2022, 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.

• 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: 15211586
• MDR Text Key: 297721622
• Report Number: 3004209178-2022-10251
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Date Device Manufactured: 12/23/2021
• 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): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male