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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial # (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial #: (b)(4) , ubd: (b)(4) 2012, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a company representative regarding a patient who was receiving lioresal with concentration 2000 mcg/ml at a dose rate of 150 mcg/day via an implantable pump for intractable spasticity.The drug lot number of lioresal was unavailable.It was reported that the patient lost effect of intrathecal baclofen (itb) with no signs of withdrawal.The event occurred during normal use.A side port study showed cerebrospinal fluid (csf) flow; however, an indium study showed no flow.The pump and complete catheter were replaced.In the operating room (or) the catheter was noted to be at l4 when initial implant note states the catheter tip at t11.The pump was interrogated and no signs of defect were noted, but the physician felt it should be replaced also to rule out all issues with the system given the patients symptoms.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the event.Other medications the patient was taking at the time of the event were not available.No further patient complications have been reported as a result of this event.The customer was notified that the product should be returned, and the pump and catheter were planned to be returned to the manufacturer for analysis.The patient¿s weight at the time of the event was unknown / would not be made available due to legal/confidential reason.The patient¿s medical history included a spine surgery that was performed in the past 12 months.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the pump on 2018-may-25 revealed no anomaly.Analysis of the catheter on 2018-may-25 revealed no significant anomaly.Analysis noted coring/tears/cuts in the seal of the sutureless connector; however, no leak was seen in the lab.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H6 correction: the previously applied conclusion code 22 was replaced with conclusion code 67.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
• MDR Report Key: 7365164
• MDR Text Key: 103289276
• Report Number: 3004209178-2018-05605
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2020

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: 07/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 05/25/2018; 01/29/2020
• Supplement Dates FDA Received: 04/04/2018; 05/25/2018; 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10....
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR