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 Date 02/15/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 15-jul-2013, 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 a healthcare provider (hcp) via a company representative regarding a patient receiving dilaudid (2 mg/ml at 0.1 mg/day) via an implanted pump.It was reported that the patient presented to the physician¿s office on (b)(6) 2022 with reports of worsening pain.A catheter access study was performed in the clinic and found to be negative for return of cerebrospinal fluid (csf).It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.A plain film x-ray had been completed on (b)(6) 2021 and showed the catheter entering at the l2 level with the tip at the t8 level.Following the negative cap (catheter access port) study, the patient was seen in the clinic for multiple follow up visits to reduce her intrathecal dosing in preparation for a catheter revision to prevent/reduce symptoms of toxicity/overdose when the drug was reinitiated.The patient was taken to the or (operating room) today and placed in a lateral position.The physician first started by opening the pump pocket.He then proceeded to dissect out the pump and existing proximal pump segment.Once this was completed, he again attempted to aspirate csf from the catheter access port but was again unsuccessful.The pump was then disconnected and placed on the sterile table.The pump connector was removed, but there was still no flow of spinal fluid, and another attempt was made to aspirate directly from the spinal segment again, but still no return of csf.The physician then proceeded to open the lumbar incision.Because the patient had an older model catheter, the hcp opted to replace the existing catheter with a newer model catheter which was placed at the t8 level, and because the existing pump had an eri (elective replacement indicator) of less than 26 months, the hcp opted to go ahead and replace it prophylactically in order to prevent an additional surgery in approximately one year.The new catheter was attached to the new pump and the hcp successfully aspirated fluid from the catheter port site.The new pump was placed back in the existing pump pocket at which time the hcp successfully aspirated csf one last time from the catheter access port.The incisions were then irrigated and closed.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: 14774290
• MDR Text Key: 294509495
• Report Number: 3004209178-2022-07963
• 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: 06/22/2022

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: 06/16/2022
• Initial Date FDA Received: 06/22/2022
• Date Device Manufactured: 08/09/2017
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 74 KG