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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/18/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was receiving (2,000 mcg day at 600 mcg day) via an implantable pump for intractable spasticity.It was reported that patient was seen in er (emergency room) and was admitted for withdrawal symptoms of increased spasms.Factors that have led to the issue was unknown.A catheter dye study was done, and the healthcare provider (hcp) was able to aspirate but was questioning if there could be a kink decreasing effectiveness of therapy.Patient was scheduled for an open revision and exploration of the catheter on (b)(6) 2022.The issue was not resolved at time of this report, the patient was alive no injury.  it was reported that the patient stated something was wrong with the pump or catheter and was scheduled to have catheter replaced tomorrow.Patient stated the hcp was only planning on replacing the catheter.Patient stated they were told the pump has 18months battery life on it and would like for medtronic representative to tell the hcp to also replace pump to save them a second surgery in the future.Patient was redirected to hcp.Patient stated "well what if they find that the problem isn't just the catheter and then they have to do a second surgery anyway; patient was again redirected to hcp.Patient stated they were currently in hospital and stated they are not sharing the information the way they felt it should be shared.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 15-sep-2018, udi#: (b)(4).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 company representative (rep) reported that the issue has been resolved.

Manufacturer Narrative

H3: the catheter was returned and analysis identified an area where the catheter had been abraded.The abrasion had breached the inner lumen of the catheter and a leak was developed.Analysis identified a hole in the catheter that is consistent with repeated flexing of the catheter.Analysis identified a kink in the catheter body.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: 13925759
• MDR Text Key: 288017448
• Report Number: 2182207-2022-00517
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

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: 05/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 03/29/2022; 06/16/2022
• Supplement Dates FDA Received: 04/05/2022; 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• 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: 39 YR
• Patient Sex: Male