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

Model Number 8637-40

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 06/15/2011

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Information was received from a patient who was receiving bupivacaine and morphine at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain and rsd/causalgia - complex regional pain syndrome.It was reported that compatibility guidelines were requested for magnetic resonance imaging (mri) which was not due to a problem with the device or therapy.The patient hadn't had his pump filled for "about a year" and his alarm had been going off "maybe last july"; the battery should have ran out in (b)(6) 2017.The patient asked if he would not be using therapy if he needed the pump taken out.Last time the patient had surgery the patient "died;" he went into respiratory arrest and was on a ventilator for 5 days.The surgery was unrelated to the device/therapy.The patient was not using the pump because the pump was "never used like it was supposed to be used." the patient's doctor "never put enough medication to do anything." the reason the patient got the pump was to reduce the amount of oral opiates he was taking as he was taking a lot.The patient's doctor insisted the patient stop taking all oral medication prior to implant.The patient "had surgery" (refers to pump implant) and had the pump in for 8 years and it had done nothing since implant.The patient's drug was "like drops" and at a minimal amount.No further complications were reported.

Event Description

Additional information was received from a consumer indicated he did not use the pump anymore and has not had it filled in probably three years.The pump was currently alarming.It was noted the patient was now experiencing pain in the pump area and felt like a burning pain.The patient inquired if there were any risks with leaving a ¿dead pump¿ in his body.The patient was wondering what he should do because his pump healthcare provider (hcp) did not have a practice anymore.No further complications were reported.

Manufacturer Narrative

All previously reported patient and device codes will be updated/corrected to the following for this event: patient codes: c3303 and c50476 device codes: c76126 review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 7353059
• MDR Text Key: 103772407
• Report Number: 3004209178-2018-05359
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2011
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR