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

Model Number 8637-20

Device Problems Device Ingredient or Reagent Problem (2910); Human-Device Interface Problem (2949)

Patient Problems Oversedation (1990); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id a810 lot# serial# unknown product type software.Other relevant device(s) are: product id: a810, serial/lot #: 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 consumer and a company representative regarding a patient receiving baclofen 2000 mcg/ml at approximately 300 mcg/day via an implanted pump.The indication for pump use was multiple sclerosis and intractable spasticity.The patient¿s representative reported that the patient¿s pump was adjusted yesterday, and the reporter believed an improper adjustment was made and now the patient was in the er (emergency room) "high as a kite and getting all kinds of baclofen".Additional information was received the same day from a company representative who reported that the patient had a dye study yesterday for a routine catheter patency check.The reporter was now on their way to the er where the patient was experiencing overdose symptoms (sedation) and they were questioning if the dye study had been conducted accurately.

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

Additional information was received from a healthcare provider (hcp) via a company representative who reported that the cause of the aspirated fluid looking a little serosanguinous was unknown.No further diagnostics were done.The patient followed up with her np (nurse practitioner) to ensure no residual effects and no issues were noted.

Manufacturer Narrative

Continuation of d10: product id 8578 serial# (b)(6) implanted: (b)(6) 2012 product type catheter product id 8709 lot# l64779 implanted: (b)(6) 2000 product type catheter product id 8578 serial# (b)(6) implanted: (b)(6) 2012 product type catheter product id 8709 lot# l64779 implanted: (b)(6) 2000 product type catheter product id a810 serial# unknown product type software 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 received from the company representative (rep) reported that they were first notified of the dye study on (b)(6) 2022for the patient while the procedure was going on.By the time the rep was able to make it to the radiology department for the dye study, it had been completed.The rep verified with the radiology physician who stated, "the cap [catheter access port] was successfully aspirated, and a few ml's of contrast were pushed through".A priming bolus per successful dye study protocol was then initiated on tablet.That evening the radiology physician called the rep (hours after procedure) and stated, "wasn't sure if what i aspirated from cap was indeed csf, it looked a little serosanguinous".The rep advised the provider to follow up with patient to ensure patient safety.The following day on (b)(6) 2022, the managing provider notified the rep that the patient was going to er with son because the patient was experiencing baclofen overdose symptoms i.E over sedated (per provider's rn (registered nurse)).The rep titrated dose down per managing provider's orders.The patient was discharged shortly after.

• 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: 15706190
• MDR Text Key: 302770647
• Report Number: 3004209178-2022-14272
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

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: 11/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/01/2022; 11/07/2022
• Supplement Dates FDA Received: 11/03/2022; 11/08/2022
• Date Device Manufactured: 06/05/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female