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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Muscular Rigidity (1968); Sleep Dysfunction (2517); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/29/2021

Event Type  Injury  

Event Description

Information was received from multiple sources (healthcare provider, foreign, clinical study) regarding a patient who was receiving an unknown drug of an unknown concentration at an unknown flex dose rate via an implantable pump for unknown indications for use.It was reported that the patient experienced increased spasms.The spasms occurred when the patient was going to the toilet, 3 to 4 times a night.In such spasms, the muscles alternate every 20 seconds.The complaints were no longer bearable, and the patient slept badly at night.The patient required hospitalization.It was further indicated that as per a telemetry (previous session date of (b)(6) 2020) a low reservoir alarm had occurred.Side port aspiration was attempted on (b)(6) 2021, and it was not possible to extract cerebrospinal fluid (csf).The side port had been punctured with a 24 gauge huber needle.It was concluded that there was a problem with the intrathecal catheter.The device diagnosis was catheter occlusion.A revision was planned to occur (b)(6) 2022.T he event was ongoing.Regarding etiology, the event was related to the device/therapy and unrelated to the implant procedure.The patient's weight was not measured at baseline.

Manufacturer Narrative

Concomitant medical products: product id: 8731, serial# (b)(4), product type: catheter.Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 19-sep-2007, udi#:(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported the implant date of the pump ((b)(6) 2019), the implant date of the catheter ((b)(6)2005), and the patient's age at time of consent (45).

Manufacturer Narrative

Continuation of d10: product id 8731 lot# serial# (b)(6).Implanted: (b)(6) 2005.Explanted: 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 received from a foreign healthcare professional (hcp) via a clinical study reported a revision was performed on 2021 (b)(6) where the catheter was explanted/replaced.The outcome of the event resolved without sequelae on 2021 (b)(6).The clinical diagnosis was increased spasms.The event resulted in medical or surgical intervention to prevent life threatening illness or permanent impairment to a body structure or body function.

Manufacturer Narrative

Continuation of d10: product id: 8731, serial#: (b)(6), implanted: 2005 (b)(6), explanted: 2021 (b)(6), 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.

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 received from a foreign healthcare professional (hcp) via a clinical study reported the clinical diagnosis was updated to increased muscle spasticity.

• 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: 12935053
• MDR Text Key: 281757943
• Report Number: 3004209178-2021-18034
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• 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: 02/15/2022
• Date Device Manufactured: 06/27/2019
• 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
• Treatment: "SEE H10...."; "SEE H10...."; SEE H10....
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male