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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problems Fall (1848); Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8709, lot#:, serial#: (b)(4), implanted: (b)(6) 2007, explanted:, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 17-oct-2008, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) regarding a patient receiving baclofen at an unknown concentration and dose via an implantable infusion pump.It was reported that after a pump replacement last year the patient had not being not getting expected relief even after a 15% of a dose increase.It was noted that the hcp who performs the patient's refills suspected a catheter issue.The caller was not aware if there are any volume discrepancies or why the home infusion company is suspecting there may be a catheter issue.It was reported that the hcp wasn't sure if there is a system issue or if it could be disease progression as patient has multiple sclerosis (ms).No further complications have been reported.

Manufacturer Narrative

H6 update: patient codes updated.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

Continuation of d11: product id 8709, serial# (b)(6) implanted: (b)(6) 2007, product type catheter h6 update: the previously applied device code c53269 was replaced with c63075 and c62897.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 via a healthcare provider (hcp) and consumer via a company representative.It was noted that the patient¿s wife reported increasing lower extremity spasticity over the last few weeks.Daily dose had been increased several times with no change in tone.The patient was described as falling frequently at home.The date of the event was unknown.Side port aspiration was negative; there was no flow.It was assumed that there was an issue with the catheter somewhere along the pathway.It was noted that x-rays were also completed but did not show any specific issue.The patient was to be sent to neurosurgery for a possible catheter revision.The issue was not resolved as of (b)(6) 2020.No surgical intervention had occurred, and no surgical intervention was planned.The patient was without injury regarding their status as of (b)(6) 2020.The pump was noted as having administered lioresal with concentration 1000 mcg/ml at a dose rate of 285 mcg/day.The patient¿s weight and medical history were noted as having been requested but was unknown or would not be made available.

• 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
• MDR Report Key: 10502673
• MDR Text Key: 205945886
• Report Number: 3004209178-2020-15511
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR