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

Model Number 8637-20

Device Problems Kinked (1339); Aspiration Issue (2883)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient receiving dilaudid (15 mg/ml at 3.7 mg/day) via an implantable infusion pump.It was reported that on an unknown date the patient had fallen and experienced a lack of efficacy.During an office visit on an unknown it was noted that there was an inability to aspirate the catheter.A catheter revision was scheduled for (b)(6) 2018; during the surgery it was discovered that cerebrospinal fluid flow was present.The healthcare provider (hcp) also checked the catheter port and confirmed flow from the pocket to the back.It was reported that no issues with the catheter were identified and it was reconnected with boots and pins.Once the catheter was reconnected it was aspirated to confirm flow.The issues was reported as resolved and the patient was alive with no injury.No further complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) indicated that the patient began not feeling well 2 weeks ago and was noted as going through withdrawal because the medication was "clogged" and not going through the pump.It was reported that during the catheter revision it was discovered that the catheter was kinked.The catheter was unkinked during the surgery and now the patient was reported as being fine.No further complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a healthcare provider via a device manufacturer representative indicated that there was no clear kink observed the catheter revision.It was reported that the surgeon assumed that there may have ben a kink that resolved upon opening the pocket.No further information was provided in regards to this event.

Manufacturer Narrative

B3: the new event date was estimated.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 from a patient.It was reported that the catheter was replaced in (b)(6) 2018 and the patient got 3 different answers from the healthcare professional (hcp) when the patient asked why this happened.The hcp told the patient it was stuffed up and the hcp said these things got old.Patient said that 3 days prior to hurricane irma in (b)(6) 2017, the patient fell in the garage on top of two jack stands and one of the jack stands impaced the left side exactly where the catheter of my pain pump ran.Patient said that "from the dilaudid, the patient went into cold turkey withdrawals from the dilaudid about 2 months after that (2017) and the pain level had skyrocketed about 3 weeks after the fall ((b)(6) 2017) and the patient told the hcp the pain was back with a vengeance and after the fall, 3 weeks later the pain came back".No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 7444193
• MDR Text Key: 105952266
• Report Number: 3004209178-2018-08422
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR