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

Model Number 8637-20

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

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Muscular Rigidity (1968); Sepsis (2067); Fungal Infection (2419); Tissue Breakdown (2681)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

Medical devices: product id neu_unknown_cath, lot# unknown, serial# unknown, implanted: unknown, product type catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown/unknown, ubd: unknown, udi#: 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

Information was received from a foreign healthcare provider (hcp) via a distributor regarding a patient receiving gabalon intrathecal of an unknown concentration at a dose rate of 409 mcg/day via an implantable pump.It was reported that the patient informed that their catheter was visible from the abdominal suture region and had asked to visit the hospital.When it was checked, the catheter was exposed from the suture region; moreover, the patient had a fever.Antibiotics were administered in consideration of the infection.The drug was gradually reduced in consideration of removal.As for the details, the next visit was to occur on the 16th, which was the weekend, so a visit will be made on the 16th.It was further reported that still the patient has just visited the hospital, and the cause of the fever is also unknown.The daily dose was 409 mcg/day, so the withdrawal symptoms were considered in preparat ion for pump removal, and for the time being it was temporarily reduced.The outcome of the adverse event / catheter exposure was unknown.Regarding causal relationship with the catheter, pump, and to the procedure, it was indicated as unknown.

Manufacturer Narrative

Continuation of d10: product id 8781 lot# unknown serial# (b)(6), implanted: (b)(6) 2018.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 via a distributor on 2022-oct-04.It was reported that the catheter was also explanted on (b)(6) 2022.The pump and catheter were discarded.

Manufacturer Narrative

Continuation of d10: product id 8781, serial# (b)(6) implanted: (b)(6) 2018, 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 via a distributor on (b)(6) 2022.The pump serial number was clarified as (b)(6).The pump was removed on the 22nd; the patient did not have any withdrawal symptoms and sometimes had severe strain, but the overall condition was stable.The antibacterial agent of the staphylococcal target and the fungus were targeted.Fungus agent treatment was also completed.The originally inserted cv of the central venous hyperalimentation was re-inserted, and botox was performed once due to strong tension on the neck.The patient will be discharged soon.There were no adverse events related to intrathecal baclofen.

Manufacturer Narrative

Continuation of d10: product id 8781 serial# (b)(6) implanted: (b)(6) 2018 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(6), ubd: 2020-03-20, 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

Additional information was received from a foreign healthcare provider via a distributor.The underlying disease was cerebral palsy.The patient underwent surgery (implant) at this hospital on (b)(6) 2018.The pump serial number was ¿(b)(6)¿ (serial number not recognized by manufacturer), and the catheter serial number was (b)(6).The onset of the catheter exposure was (b)(6) 2022.The patient was becoming thin from the start and pus appeared around the wound in the operation.In this case, pus developed along the wound, and it was believed that it had developed, but the mold was also growing around the central vein.The fungus in the blood was also believed to be the cause.As of (b)(6) 2022, it was indicated that the first report was received on (b)(6).The patient's refill was scheduled for the (b)(6), and in the area around the abdominal pocket that was opened, the catheter was visible.The patient had also developed a fever of an unknown cause, but after this, the patient was to be moved to the hospital.The patient required hospitalization / prolongation of hospitalization.Also, it was noted that the details were to be obtained at the time of the visit on the (b)(6).After that, it was reported via email that it was a septicemia condition in the findings at the time of the hospital visit.There was no rubefaction at the infection, and the fever was obvious.Staphylococcus was detected in the abdominal release region, and fungi were detected in the blood.It was now the (b)(6) of dose reduction, and currently, the dosage had been successfully reduced.Removal was aimed on the (b)(6).It was decided that after proceeding with the dosage reduction to the extent possible, the removal was targeted.Initially, the daily dose was 480 mcg/day, and the dose was reduced to the scr dose by about 10 days.It was noted that the intrathecal baclofen (itb) therapy had been performed for a long time.It was indicated that itb therapy was unlikely to be the cause of the current event; was not considered a suspected drug.The causal relationship with drug / gabalon was not related.Regarding outcome, the patient had not recovered as of (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: 15431679
• MDR Text Key: 300030194
• Report Number: 2182207-2022-01748
• 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,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Date Device Manufactured: 04/06/2018
• 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...."; SEE H10.; SEE H10.; SEE H10.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Male