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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2022, product type : catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 15-mar-2019, udi#: (b)(4).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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving unknown morphine drug (2 mg/ml at 0.1 mg/day) via an implantable pump for non-malignant pain and degenerative disc disease/herniated disc pain.It was reported that the patient was seen in clinic on (b)(6) 2022 with complaints of poorly controlled pain.A catheter access study was done in clinic and found to be negative.In preparation for a catheter revision, the patient¿s dose was subsequently reduced on multiple follow up visits in order to prevent overdose/toxicity when the infusion was restarted.Due to the fact that the patient only had 22 months of battery life remaining on their pump, the physician also opted to go ahead and replace the pump today in order to prevent another surgery in the next 12 to 18 months.A factor that may have contributed to the issue included body habitus.There were no history of recent falls.The patient was taken to the operation room on (b)(6)2022 and placed in a left lateral position.The physician started by opening up the pump pocket and removing the old pump.Once the pump was out of the pocket, the physician again attempted to aspirate from the catheter access port, but there was still no return of csf (cerebrospinal fluid).At this time, the physician decided that they were going to replace the catheter in its entirety.They tied off the pump segment within the abdominal pocket and abandoned the catheter.The patient was given a new 8780 catheter that was untrimmed and placed at the t8 level.It was then tunneled over to the existing pump pocket and attached to the new pump.They then again aspirated from the catheter access port and had positive return of csf.The issue was resolved at the time of report.The patient's medical history was asked but unknown.The patient's status at the time of report was alive - no injury.

• 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: 15543953
• MDR Text Key: 301189212
• Report Number: 3004209178-2022-12192
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

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: 01/28/2019
• 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: 09/15/2022
• Initial Date FDA Received: 10/05/2022
• Date Device Manufactured: 08/02/2017
• 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 Sex: Female
• Patient Weight: 88 KG