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

Model Number 8637-40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Excessive Heating (4030)

Patient Problems Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 20-aug-2016, 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 via a device manufacturer representative regarding a patient receiving hydromorphone (20 mg/ml at 9.681 mg/day) via an implantable infusion pump.It was reported that the patient had a pocket revision in (b)(6) 2019.The patient has been having a complaint about the pump heating up in the pocket since (b)(6) 2020.It was noted that the patient had a dye study on (b)(6) 2020 and a mri to follow.The doctor did a pump exploration of the pocket and a catheter revision.It was noted that due to scar tissue they couldn't take out the old catheter and ran a new catheter along the old one.After the revision the patient still complained of heat from the pocket.The caller stated that 7 weeks ago part of the pocket felt hot on the outside and the inside and was hot to the touch.The device had been interrogated and nothing was found.(b)(6) 2021 (rep): additional information was received from the device manufacturer representative indicated that patient stated the pocket revision was done due to the patient experiencing a ¿hot and burning feeling¿ at the pump pocket site.It was noted that the patient was going to be seen on (b)(6) 2021, due to ongoing symptoms of ¿pump pocket feeling hot.¿ (b)(6) 2021 (rep); document contained no new information.

Manufacturer Narrative

The aware date is being updated and the report is not late.Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2014 product type catheter product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2020 product type catheter.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: 12052063
• MDR Text Key: 264455375
• Report Number: 3004209178-2021-09850
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR