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

Model Number 8637-20

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: (b)(6) 2001, udi#: (b)(4).Implanted: (b)(6) 1999, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via manufacturer representative regarding a patient who was receiving an unknown drug at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain and failed back surgery syndrome.It was reported that the 8578 catheter was added to replace the damaged portion of the 8709 catheter, which was still the primary catheter.There were no reported symptoms.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Conclusion code 22 no longer applies and instead conclusion code 67 applies.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 received from manufacturer representative (rep) on 2018-jul-10 indicated the cause of the catheter damage was not determined.The surgeon hypothesized that it might have been from a needle poke during refill.It was unknown when the catheter damage occurred.It was only observed during a routine pump placement due to "enderi".It was noted that during the pre-surgery interrogation the patient did not have any complaints about the therapy.It was noted that a healthcare professional (hcp) notified the manufacturer representative (rep) when they noticed what was believed to be a leak.The rep was notified on 2018-jul-03.It was noted that the explanted catheter would not be returned for analysis as it was discarded by the hcp.The pump was explanted for elective replacement due to pump nearing end of service.The patient's status is alive and well.The patient's weight was unknown.The information was confirmed with physician/account.No further complications were reported/anticipated.

• 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: 7675932
• MDR Text Key: 113619571
• Report Number: 3004209178-2018-15452
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention